Selecta® 7000 - Lumenis Ophthalmology

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Selecta® 7000
FDA PREMARKET NOTIFICATION 510(K)
CLINICAL PERFORMANCE REPORT

1.0 | Background and Rationale for SLT
Lasers have been employed in the management of glaucoma for over two decades, in a range of
procedures that include iridotomy, gonioplasty, goniotomy, sclerostomy, trabecular ablation and
trabeculoplasty. The early work of Worthen and Wickham 1,2 established that a continuous wave argon
laser could be safely used to photocoagulate the trabecular meshwork, with significant decreases in
intraocular pressure that were maintained over a period of months. Several years later, Wise and
Witter, 3 using lower laser energy in the procedure known as argon laser trabeculoplasty or ALT,
reported successful reduction of intraocular pressure in a population of patients who had failed
medical therapy.
ALT was initially adopted as an alternative or adjunct to medical therapy in order to reduce intraocular
pressure in patients who had failed medical therapy and thereby postpone or obviate the need for
surgery. Over time, as the pressure-lowering effect of and safety of ALT were confirmed, use of this
procedure as the starting point for management of primary open angle glaucoma emerged. In the
Glaucoma Laser Trial, 4-7 initial treatment with argon laser trabeculoplasty was shown to have a greater
pressure-lowering effect than medication (timolol maleate 0.5%) at 2 years of follow-up. Additionally,
at two years of follow-up, fewer of the laser-treated eyes required simultaneous administration of two
or more glaucoma medications to control intraocular pressure. 5 While there were no major differences
between the two treatment arms with respect to changes in visual acuity or visual field over the first
2 years of follow-up, at 3.5 years the mean threshold per test location of the visual field was higher for
eyes initially treated with ALT than for the eyes initially treated with medication. 6 The results at 5
years of follow-up were consistent with the earlier outcome, with respect to intraocular pressure level,
visual field results, optic disc status, visual acuity and medication use, which continued to be lower in
the eyes initially treated with laser. While none of the differences between the treatment groups were
large, all of these differences suggested that initial treatment with ALT in patients with primary openangle
glaucoma was at least as effective as intervention with timolol. 7
Although ALT has been shown to be a viable alternative to initial treatment with medications, its use
in this population has been limited by several factors, particularly the underlying coagulative damage
to the trabecular meshwork induced by the procedure. It has been established that laser trabeculoplasty
reduces intraocular pressure by increasing aqueous outflow, 8-10 however the mechanism for
improved outflow has not been fully elucidated. Two general hypotheses have been advanced to
explain the increase in aqueous outflow following laser trabeculoplasty. One of these suggested
mechanisms is that ALT induces a biologic response in the trabecular meshwork which involves
increased trabecular cell division and migration of trabecular cells to the burn areas, and phagocytosis
of debris, production of glycosaminoglycans (GAGs), and activation of metalloproteases involved in
the maintenance of the extracellular matrix, all of which are normal functions of the trabecular
meshwork cells. 11,12 This has been supported by Alvarado and Murphy, 13 who examined outflow
obstruction in pigmentary and primary open angle glaucoma and demonstrated that macrophages
are the major cell type responsible for trabecular meshwork clearance of pigment and debris.
1

21.0 | Background and Rationale for SL T
While the role of the biologic response elicited by ALT continues to be a subject of investigation,
the mechanical and thermal effects on the trabecular meshwork tissue following ALT have been well
documented. Histopathologic and scanning electron microscopic studies of the trabecular meshwork
suggest that laser energy may induce an inner bowing of the trabecular meshwork, adequate to open
Schlemm’s canal. 14 However, this has not been confirmed by other investigators in histologic analysis
of laser-treated cadaver eyes. 15 Furthermore, while some of the effects observed histologically may
increase aqueous outflow, others may be responsible for the reported failures of the ALT procedure.
Coagulative necrosis caused by thermal injury of the treated tissue, and disruption of trabecular
beams with fragmented cells and fibrocellular tissue in the juxtacanalicular region of the trabecular
meshwork were observed in cynomolgus monkeys following ALT. 16 In ALT-treated human eyes,
histopathologic examination of samples obtained at trabeculectomy revealed early changes similar to
those observed in monkeys, with disruption of trabecular beams, and accumulation of cellular and
fibrinous debris. 14 In tissue samples obtained 6 to 12 months following ALT, confluent areas of fibrosis
and occlusion of the trabecular spaces by abnormally migrating corneal endothelial cells were
observed. 14 Such changes in the architecture of the trabecular meshwork ultimately result in trabecular
fusion and/or occlusion of the trabecular spaces, leading to obstruction of aqueous outflow, as
demonstrated by Melamed 16 in studies in primates which established that aqueous flow is reduced in
the area treated with argon laser trabeculoplasty. These changes may cause or contribute to the elevated
post-treatment intraocular pressure observed following ALT, and to the limited success of ALT retreatment.
17-21 In studies evaluating the outcome of ALT retreatment, only a very limited proportion of
patients experienced a reduction of intraocular pressure. Repeat ALT appears to have little chance of
success in eyes that previously failed to respond to treatment for a prolonged period of time, and may
be followed by such a substantial increase in intraocular pressure that immediate surgical intervention
is required. 17,19
Thus, the ultrastructural changes of the human trabecular meshwork following ALT comprise both
stimulating and destructive events. While laser-stimulated trabecular cell division after ALT may have
a positive effect on outflow resistance by causing alterations in the synthesis of the proteoglycan
components of the extracellular matrix, 22 the destructive mechanisms and excessive repair response
associated with ALT are related to treatment failure. These limitations of ALT, related primarily to
its coagulative effect on the trabecular meshwork, have led to interest in the development of laser
procedures that may be less destructive to the tissue of the trabecular meshwork while retaining the
therapeutic benefits of laser irradiation. In the ALT procedure, performed with continuous wave
lasers with pulse durations in the millisecond range or greater, although laser energy is absorbed
primarily by pigment-containing cells of the trabecular meshwork, there is thermal dissipation from
the pigmented cells to surrounding tissues, causing thermal coagulation of tissue. This thermally
mediated damage to contiguous tissues can be limited by means of selective photothermolysis, which
relies on selective absorption of a short laser pulse to generate and confine heat to pigmented targets.

These targets must have greater optical absorption than the surrounding tissues. Initially developed
with oxyhemoglobin as the target pigment, selective targeting or photothermolysis has been utilized
in the treatment of ectatic blood vessels found in port wine stains and in skin telangiectases. 23,24
Treatment of cutaneous pigmentation has been achieved using melanin as the target chromophore. 25-27
Selective targeting can also be applied to laser treatment of the pigmented trabecular meshwork cells.
Latina and Park 28 demonstrated that a 532 nm Q-switched, frequency-doubled Nd:YAG laser with
nanosecond pulse duration is capable of selective targeting of pigmented trabecular meshwork cells
without collateral thermal damage to the adjacent non-pigmented trabecular meshwork cells and
underlying trabecular beams. Based on this mechanism of selective targeting of pigmented trabecular
meshwork cells, Selective Laser Trabeculoplasty, or SLT, is proposed as an alternative to ALT in the
management of glaucoma.
This report on performance data generated with the Coherent Selecta 7000 serves to establish substantial
equivalence of this laser to predicate devices indicated for use in laser trabeculoplasty, and to
demonstrate that the lower pulse energy and shorter pulse duration of the Coherent Selecta 7000
results in selective destruction of pigmented trabecular meshwork cells, with minimal or no damage
to non-pigmented cells and collagen beams of the trabecular meshwork, as compared to trabeculoplasty
performed with the predicate devices.
1.0 | Background and Rationale for SLT
3

42.0
| Coherent Selecta 7000
Selective Laser Trabeculoplasty (SLT) is performed using the Coherent Selecta 7000, a frequencydoubled,
Q-switched Nd:YAG laser which delivers single laser pulses of 0.1 to 2.0 millijoules per
pulse with a pulse duration of approximately 3 nanoseconds. This low energy, short pulsed laser
treatment confines thermal damage to cells containing the target pigment or chromophore; in the
case of trabecular meshwork, this target is represented by the pigmented cells. In addition to
targeting the pigmented cells, the nanosecond pulse duration is a key factor in preventing collateral
thermal and coagulative damage, since the pulse duration is less than the thermal relaxation time of
1 microsecond for the melanin chromophore in the pigmented cells. The thermal relaxation time is
the time required by the chromophore, in this case melanin, to convert the absorbed electromagnetic
radiant energy into heat energy. When the deposition of radiant energy is rapid, as with a nanosecond
pulse, only minimal conversion of radiant energy to heat occurs. Thermal dissipation to surrounding
tissue is limited, as is coagulative damage, such that even in the treatment area, non-pigmented cells
and structures are unaffected.

Preclinical evaluation of the Coherent Selecta 7000 laser has been conducted with the objective of
demonstrating that this laser can selectively target pigmented trabecular meshwork cells while sparing
adjacent, non-pigmented cells and tissues from coagulative damage. Additionally, testing was performed
to establish the appropriate treatment parameters for selective targeting of pigmented trabecular
meshwork cells and to evaluate the acute morphologic changes following selective laser trabeculoplasty.
In vivo evaluation of SLT in cynomolgus monkeys was conducted to further establish the selective
targeting of SLT in the ocular tissue, and to better define the underlying mechanism of action of SLT.
3.1.1 In Vitro Studies to Determine Laser Effects in Trabecular Meshwork Cells
(Thermal Effects of Laser Treatment)
In a series of experiments conducted in pigmented and non-pigmented trabecular meshwork cells,
three laser systems were used to evaluate threshold response, selected targeting of pigmented cells,
and effects that are evident on transmission electron microscopy. 28 The laser systems were: (1) a
continuous wave argon-ion laser; (2a) a flashlamp-pulsed dye laser with pulse duration of 8
microseconds; (2b) a flashlamp-pulsed dye laser with pulse duration of 1 microsecond; (3a) a
Q-switched frequency-doubled Nd:YAG laser emitting at 532 nm with a 10-nanosecond pulse duration,
and (3b) a Q-switched normal mode Nd:YAG laser emitting at 1064 nm and with a 10-nanosecond
pulse duration. Pigmented trabecular meshwork cells were generated by challenging confluent trabecular
meshwork cell cultures with melanin.
3.0 | Preclinical Studies
Determination of threshold response was performed by irradiating cell cultures of pigmented and
non-pigmented trabecular meshwork cells at various radiant exposures. Control cells were prepared
by challenging non-pigmented trabecular meshwork cells with latex microspheres to determine the
effect of laser irradiation on cells with particulate material but without the chromophore presented in
the pigmented cells. The threshold radiant exposure was defined as the exposure where 50% cell
cytoxicity was observed. Following determination of threshold radiant exposure, the three types of
cell cultures were irradiated at radiant exposures ranging from sub-threshold to supra-threshold, to
determine the range where selective targeting could be achieved. Cell cytoxicity and selectivity was
determined using a fluorescent viability/cytotoxicity assay performed within 30 minutes of laser irradiation.
Cells were also prepared for transmission electron microscopy (TEM) in order to determine the
extent of cellular and intracellular damage, and to evaluate damage to adjacent non-pigmented cells.
Following irradiation of the cell cultures with each of the laser systems evaluated, there was no evidence
of cellular injury in the non-pigmented trabecular meshwork control cells and in the control cells
with latex microspheres over a fluence of 10-10 6 mJ/cm 2 . Selective targeting of pigmented trabecular
meshwork cells was achieved at threshold radiant exposures with the flashlamp pumped dye laser at
588 nm with 1-microsecond pulse duration and the frequency-doubled Q-switched Nd:YAG laser at
532 nm and 10-nanosecond pulse duration. With these two lasers, irradiation with fluences greater
than 20 times the threshold exposure dose resulted in complete (i.e., 100%) cytotoxicity of pigmented
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| Preclinical Studies
63.0
trabecular meshwork cells. It was not possible to achieve selective targeting of only pigmented trabecular
meshwork cells using either the continuous wave argon-ion laser emitting at 514 nm or the
flashlamp-pulsed dye laser emitting at 590 nm with a 8-microsecond pulse. With these lasers, both
pigmented and non-pigmented trabecular meshwork cells within the irradiation zone were non-selectively
injured, and at fluences greater than threshold, many cells within the irradiation zone were
vaporized. However, selective targeting of pigmented cells without injury to adjacent non-pigmented
cells was achieved using pulse duration of 1 microsecond or less. The adjacent non-pigmented cells
showed no evidence of cellular damage, and the damage to the pigmented cells was so subtle that
these cells were difficult to differentiate morphologically from the other cells. This suggests that not
only can pigmented cells be selectively targeted, but that this targeting can be accomplished without
gross disruption of the cellular architecture.
Transmission electron microscopy was used to assess the extent of cellular and/or intracellular damage,
and the extent of damage to adjacent non-pigmented cells. Following irradiation with a 10-nanosecond
pulse, intracellular damage was noted in pigmented cells, while there was no evidence of ultrastructural
damage to adjacent non-pigmented cells, further supporting the confinement of laser damage only to
pigmented cells.
These findings established the ability of single laser pulses of short pulse duration and low fluence to
selectively target pigmented trabecular meshwork cells in which melanin serves as the chromophore
or target to absorb laser energy. In this study, large irradiation zones or spot diameters (ranging from
200 µm to 2 mm) were utilized; this is in contrast to the smaller spot diameters (50 µm) utilized clinically
in ALT procedures. Because tissue effects are localized at the subcellular level without collateral
thermal coagulative damage, the irradiation zone can be of any shape. Additionally, the data generated
in this study suggest that the appropriate laser parameters established in the trabecular meshwork cell
culture system are equivalent to treatment parameters used clinically in ALT. Irradiation of pigmented,
non-pigmented and control cells with an argon-ion laser emitting at 514 nm yielded threshold powers
for cell damage consistent with treatment powers used clinically when performing ALT.
3.1.2 In Vitro Studies to Evaluate Cytokine Responses to ALT and SLT (Biological Effects
of Laser Treatment)
The thermal effects of ALT elicit a healing process that includes cellular responses which can lead to
either the improvement or deterioration of the function of the trabecular meshwork. For example,
while macrophages are recruited to the area of themal damage for the trabecular meshwork clearance
of pigment and debris that relieves obstruction in aqueous outflow, at the same time, trabecular cell
division within the first few days after ALT 29 can counterbalance macrophage activity via scar formation,
which can lead to eventual blockage of outflow. A series of studies have been undertaken to elucidate
the cellular and biochemical responses to ALT that occur in the trabecular meshwork, and to compare
these to the responses of this tissue to SLT, also at the cellular level.

Since it is known that metalloproteinases are involved in the turnover, remodeling and maintenance
of trabecular extracellular matrix, 22 several groups of investigators examined the regulation of metalloproteases
and their inhibitors. 30,31 To test the hypothesis that extracellular matrix turnover mediated
by matrix metalloproteinases modulates aqueous humor outflow facility, perfused human anterior
segment organ culture was utilized. 30 Purified matrix metalloproteinases, tissue inhibitors of metalloproteinases
(TIMPs), and synthetic inhibitors of matrix metalloproteinases were added to the perfusion
medium. In this model, addition of interleukin-1 alpha (Il-1 alpha) increased outflow facility, while
inhibition of endogenous trabecular metalloproteinase activity using TIMP reduced outflow rates.
These changes in outflow rates were reversible, with changes requiring 1 to 3 days, suggesting that
modulation of matrix metalloproteinases and their inhibitors can be important in the regulation of
aqueous humor outflow following laser trabeculoplasty.
In another of these studies designed to examine modulation of trabecular meshwork matrix metalloproteinase
expression, porcine trabecular meshwork cells were treated with several doses of various
growth factors and cytokines, and the culture media was analyzed after 24, 48 and 72 hours. The
most significant effects on trabecular matrix metalloproteinases were observed with tumor necrosis
factor (TNF) alpha and beta, and interleukin-1 alpha. Other growth factors and cytokines elicited
only small to negligible effects. 31 Thus, certain cytokines may play a role in trabecular cell regulation,
thereby affecting aqueous humor outflow.
3.0 | Preclinical Studies
To further evaluate the factors that mediate matrix metalloproteinase expression, human anterior segment
organ cultures were subjected to argon laser treatment (ALT) using standard clinical parameters, and
then returned to culture. 32 The resulting culture medium was then applied to fresh anterior segment
organ cultures, and was shown to induce typical trabecular cell division, as well as elevated levels of
interleukin-1 beta (IL-1 beta) and tumor necrosis factor (TNF) alpha. Thus, ALT induced the expression
and secretion of both of these cytokines, which in turn initiate remodeling of the juxtacanalicular
extracellular matrix, restoring normal outflow facility.
Alvarado and colleagues further expanded on these findings by evaluating the response of trabecular
meshwork cells to both ALT and SLT, to assess the cellular response, and to evaluate cytokine induction
in response to laser exposure. 33 Both the time course, as well as the magnitude of induction of the
cytokine interleukin-1 alpha were evaluated following ALT and SLT, while induction of TNF-alpha
and interleukin-1 beta were assessed after exposure to SLT. Both ALT and SLT treatment of cultured
trabecular meshwork cells resulted in induction of interleukin-1 alpha, with a dose-dependent
response observed following SLT performed with energy at 0.1 mJoule and at 1.0 mJoule. While minimal
levels of intraleukin-1 alpha were induced with laser treatment at 0.1 mJoule, induction of this
cytokine increased substantially with laser treatment of 1.0 mJoule, and with increasing concentrations
of melanin in the cell culture. Following exposure to SLT, levels of TNF-alpha and interleukin-1
beta were also increased in a dose-dependent fashion. Thus, with higher levels of laser energy, higher
concentrations of these cytokines were generated by cultures of trabecular meshwork cells. These
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83.0
investigators postulate that the selective induction of interleukin-1 alpha by both ALT and SLT plays
an important role in directing injured trabecular meshwork cells toward the established pattern of
wound-healing activities. In addition to the effects of cytokines in initiating remodeling of the juxtacanalicular
extracellular matrix, and thereby contributing to increased outflow facility, as described
above, changes in the glycosaminoglycans of the trabecular meshwork, and the recruitment of
macrophages following ALT and SLT may also be a result of interleukin-1 alpha induction. 33
3.2 Ex Vivo Study (Human Globes)
The acute morphologic changes induced by selective laser trabeculoplasty (SLT) were assessed using
scanning and transmission electron microscopy, and were compared to the tissue effects induced by
ALT using human eye bank eyes. 34 Half of the trabecular meshwork of each of 8 eye bank eyes was
treated with ALT, and the other half with SLT, using the Coherent Selecta 7000 frequency-doubled
Nd:YAG laser. Following laser treatment, specimens were submitted for evaluation by light
microscopy, scanning electron microscopy (SEM) and transmission electron microscopy (TEM).
In trabecular meshwork treated with ALT, scanning electron microscopy revealed crater formation in
the uveal meshwork, with scrolling, whitening and bleb formation of the surrounding collagen, coagulative
damage, and disruption of the endothelial cells. In contrast, SEM performed in SLT-treated
trabecular meshwork revealed no evidence of crater formation, minimal evidence of mechanical
damage, and intact uveal meshwork and corneal scleral trabecular sheets.
Transmission electron microscopy (TEM) performed following ALT revealed disrupted trabecular
meshwork, with fragmentation and fusion of the collagen framework and the trabecular endothelial
cells. Similar evaluation of the trabecular meshwork following SLT revealed corneoscleral meshwork
of normal appearance, with only minor disruptions in the pigmented meshwork cells.
This morphologic comparison demonstrates that ALT causes disruption of the trabecular beams of
the uveal and corneoscleral meshwork, with coagulative damage. In contrast, following SLT, there
was no alteration of the collagen structure and central core regions of the trabecular beams in the
uveal and corneoscleral meshwork.
3.3.1 In Vivo Study (Primates) — Trabecular Meshwork Histology Following SLT
The acute effects of SLT on the morphology of trabecular meshwork were evaluated in owl monkeys,
a model chosen for the close resemblance of its trabecular meshwork structure and pigmentation to
that of humans. 35 The SLT procedure was performed on the eyes of four primates, however half of
each eye (either nasal or temporal 180°) was left untreated. The animals were sacrificed at 24 hours
or 28 days, and tissue sections from each quadrant were processed for light and electron microscopy.
Histologic evaluation of tissue of untreated tissue from the 24-hour sacrifice revealed compact, highly
cellular trabecular meshwork with healthy cells lining the collagen beams, i.e., with normal morphology.
Examination of tissue exposed to SLT revealed disrupted pigmented trabecular meshwork cells, and

cell debris, as well as pigment within the aqueous channels. However, the overall architecture of the
trabecular meshwork, including the integrity of the inner wall of Schlemm’s canal, was well preserved
without evidence of thermal damage. Similar histologic observations were made at 28 days. The
trabecular meshwork structure was well preserved with an intact Schlemm's canal and healthyappearing
non-pigmented trabecular meshwork cells lining the inner wall. Several engorged
macrophages were present in the trabecular meshwork.
The results of this histologic evaluation confirm the selective targeting of pigmented trabecular
meshwork cells by SLT, and the absence of thermal damage to underlying tissue and structures in
the trabecular meshwork.
3.3.2 In Vivo Study (Primates) — Biological Effects of Laser Treatment
Alvarado 13 has proposed that monocytes which normally circulate in small numbers in the aqueous
humor are activated and transformed into macrophages upon interacting with injured tissues.
Introduction of macrophages into the anterior chamber results in a rapid and persistent increase in
outflow facility, 13 while the presence of dead macrophages has been associated with a marked obstruction
of aqueous outflow. 36 Following ALT, numerous macrophages are observed in the trabecular
meshwork; these cells engulf melanin granules, reach an enormous size and clear the pigment granules
from the trabecular meshwork via Schlemm’s canal. In cynomolgous monkeys treated with SLT, the
number of monocytes and macrophages was found to be 5- to 8-fold higher than in the untreated
controls. These findings suggest that injury to pigmented trabecular meshwork cells induced by SLT
results in the release of factors and chemoattractants which recruit macrophages in a manner similar
to that previously observed for ALT. This recruitment of macrophages by both ALT and SLT may be at
least in part responsible for the increased aqueous outflow facility observed following these procedures.
3.0 | Preclinical Studies
Scanning electron microscopy of the trabecular meshwork tissues in the cynomolgous monkeys treated
with SLT revealed no localized effects of treatment, such that treated and untreated tissues were indistinguishable
from each other.
3.4 Summary of Preclinical Studies
The extensive preclinical investigations summarized herein serve to establish the ability of the Q-switched,
frequency-doubled Nd:YAG laser, emitting at 532 nm with pulse duration in the nanosecond range,
to selectively target pigmented trabecular meshwork cells, utilizing melanin as the target chromophore.
By selectively targeting pigmented cells, thermal damage to surrounding cells and tissue was avoided.
These observations are consistent with previously reported data on selective photothermolysis, in
which the use of a short laser exposure confines thermal damage to the target (i.e., melanin), if it is
equal to or shorter than the thermal relaxation time of the target. 37 With the thermal relaxation time
for melanin at approximately 1 microsecond, pulses with duration of less than 1 microsecond deposit
energy within the target more rapidly than this energy can diffuse away. While the temperature within
9

3.0 | Preclinical Studies
the target, in this case pigmented trabecular meshwork cells, increases to levels adequate to cause
selective cellular destruction, thermal diffusion to surrounding non-pigmented cells is minimized.
This selective targeting of pigmented cells was reflected in the morphologic evaluation of both irradiated
cell cultures of trabecular meshwork cells, and actual trabecular meshwork from human eye bank
eyes. In both cases, changes in cellular ultrastructure were observed only in pigmented trabecular
meshwork cells, while adjacent non-pigmented cells and tissues were spared. This was confirmed in
primate eyes, in which SEM revealed no localized effects following SLT. This was in contrast to the
tissue exposed to ALT, in which non-specific destruction of trabecular meshwork cells, and thermal
damage to underlying and adjacent collagen beams were observed. Additionally, the significant
increase of macrophages in primate eyes following SLT, as has been reported following ALT, confirms
the contribution of biologic effects to the usefulness of both of these procedures.
10

In addition to the definitive body of preclinical data establishing the effect of SLT on the trabecular
meshwork, extensive supportive clinical data have been generated on the SLT procedure. Clinical
experience with SLT gained from evaluation of over 1,100 eyes treated in prospective clinical studies
around the world supports both the safety and effectiveness of this procedure as an alternative to ALT.
This clinical experience with the Coherent Selecta 7000 laser for laser trabeculoplasty is summarized
in a table on the following pages. As shown consistently in the summary information, reduction of
intraocular pressure following SLT was very similar to the decrease in IOP reported for eyes that
underwent ALT in the control arms of these studies. And while the number of eyes in the ALT control
groups was relatively small, particularly in comparison to the large number of eyes treated with SLT,
the observations reported in this population of eyes were consistent with the extensive published
literature on ALT, with regard to both intraocular pressure reduction and safety of the procedure.
More detailed information on several of the key trials follows the table of worldwide clinical studies
of the Coherent Selecta 7000 laser used to perform selective laser trabeculoplasty, or SLT.
4.0 | Supportive Information — Clinical Experience with SLT
11

124.0 | Supportive Information — Clinical Experience with SL T
Table 1A Worldwide Clinical Studies of the Selective Laser Trabeculoplasty (SLT)
Author Publication Study Design Number Duration Baseline IOP IOP at Decrease Other Comment
of Patients of Follow-up (mean, S.D.) Follow-up in IOP Outcomes
(mean, S.D.)
Anschutz - Prospective, 398 12–24 months 22.3 mmHg 17.9 4.4 mmHg 38% of eyes 82% of
single arm (12 months) (19.8%) required no patients
18.2 (12 months) glaucoma responded
(24 months) 4.1 mmHg medication, with IOP
(18.4%) 52% reduced reduction
(24 months) the use of ≥3 mmHg
glaucoma
medication
Damji et al. British Jour Prospective, ALT - 42 6 months 23.6 mmHg ALT: ALT: – No change in
Ophthalmol randomized SLT - 35 for both groups 18.3 mmHg 5.0 mmHg IOP in
1999;83: SLT vs ALT SLT: SLT: untreated
718–722 38 18.0 mmHg 5.2 mmHg fellow eyes
(20%)
Garza-Saide – Prospective, 24 Average 27.6 mmHg 18.2 mmHg 9.4 mmHg Transient –
et al. feasibility, 32 weeks (33%) increase in IOP
2 clinical sites postprocedure
in 7 eyes (24%)
Goulas et al. – Non-randomized ALT - 159 3 years ALT: ALT: ALT: 27% SLT group
comparison of SLT - 42 24.3 mmHg 17.8 mmHg SLT: 28% had significant
ALT and SLT (S.D. 4.2) (S.D. 3.1) decrease in
(subgroup of SLT: SLT: use of
study under 23.9 mmHg 17.2 mmHg glaucoma drugs;
G960194) (S.D. 4.2) (S.D. 3.9) no effect in
ALT group –
Hong – Prospective, 20 3 months 20.5 mmHg 14.2 mmHg 30%
single arm study – –

4.0 | Supportive Information — Clinical Experience with SLT
13
Worldwide Clinical Studies of the Selective Laser Trabeculoplasty (SLT) cont’d
Author Publication Study Design Number Duration Baseline IOP IOP at Decrease Other Comment
of Patients of Follow-up (mean, S.D.) Follow-up in IOP Outcomes
(mean, S.D.)
Kano et al. Nippon Ganka Prospective, 67 6 months 22.4 mmHg 18.0 mmHg 20% Transient increase –
Gakkai Zasshi single arm study in IOP in 25%
1999;103: of cases
612–616 39
Table 1A
Kaulen et al. – Prospective, 221 12 months 24.7 mmHg 17.9 mmHg 23% – –
single arm study
Kim et al. Ophthalmic Prospective, 13 pts 1 year 24.4 mmHg 19.5 mmHg 20% Transient increase –
Surgery & Lasers single arm study (16 eyes) in IOP in 13%
2000;31: of cases, managed
394–399 40 with apraclonidine
Lachkar et al. – Prospective, 24 eyes 5 weeks 24.6 mmHg 17.7 mmHg 28% Transient increase –
single arm study
in IOP in 2 eyes
Lanzetta et al. British Journal Prospective, 8 6 weeks 26.6 mmHg 16 mmHg 40% One eye with No significant
of Ophthalmol single arm study (S.D. 7) (S.D. 2.6) a transient anterior
1999;83:29–32 41 increase in IOP chamber
cell/flare
Latina et al. Ophthalmol Prospective, 125 26 weeks 25.3 mmHg 20.9 mmHg 17% 9 eyes (7%) Cell/flare
1998;105: single arm study had transient transient,
2082–2090 42 increased IOP minimal/mild
Rozsival et al. – Prospective, 171 Average – – Decrease IOP No significant Transient,
single arm study 6 months >3 mmHg in postprocedure mild AC cells
146 eyes (85%) increase in IOP and flare
13

144.0 | Supportive Information — Clinical Experience with SL T
4.1 A Prospective, Multicenter Clinical Trial — Frequency Doubled Nd:YAG Ophthalmic
Laser for Selective Laser Trabeculoplasty
4.1.1 Methods
A multicenter, prospective clinical study was conducted by Coherent Medical Group under IDE
G960194 to evaluate the Coherent Selecta 7000 for use in performing laser trabeculoplasty (SLT) to
reduce intraocular pressure in patients with open-angle glaucoma. A total of 125 patients were
enrolled at four clinical sites. The study population included patients with uncontrolled open-angle
glaucoma who were on maximum tolerated medical drug therapy (Max Rx group) as well as patients
who had previously failed laser trabeculoplasty (PFLT group). Treatment with the Coherent Selecta 7000
was performed over 180° of the trabecular meshwork, and patients were then followed for 26 weeks.
4.1.2 Results
4.1.2.1 Demographics and Baseline Information
Of the 125 patients enrolled in the study, data were available for 122 patients and 120 of the 122
patients underwent SLT; two patients did not meet the entry criteria and therefore were not treated.
Demographic information, as well as information on patient status at entry into the study are shown
in Table 1.
Table 1: Demographic Information and Baseline Characteristics (N=120)
Age (years) 67.7(S.D. 10.7; range 29 to 90)
Sex (% female) 65 (54.2%)
Race
Caucasian 77 (64.2%)
Black 34 (28.3%)
Hispanic 9 (7.5%)
Diagnosis*
Primary open-angle 99 (82.5%)
Pseudoexfoliative 7 (5.8%)
Pigmentary 7 (5.8%)
Other 9 (7.3%)
*Several patients had multiple diagnoses.
The majority of patients enrolled (82.5%) presented with primary open-angle glaucoma. Other
diagnoses included pseudoexfoliative glaucoma, pigmentary glaucoma, mixed mechanism glaucoma,
open-angle glaucoma in pseudophakia, and juvenile open-angle glaucoma; several patients had
multiple diagnoses, including a patient with both pigmentary and pseudoexfoliative glaucoma.

4.1.2.2 Intraocular Pressure Reduction
At 26 weeks post-SLT, a significant decrease in intraocular pressure as compared to baseline IOP was
observed, with a mean decrease in IOP of 4.4 mmHg for the overall study population. Patients with
higher intraocular pressure at baseline experienced a larger decrease in IOP than those patients with
lower initial IOP. A small decrease in IOP was also observed in untreated fellow eyes, however the
magnitude of change from baseline in fellow eyes was insignificant when compared to the significant
improvement in IOP in the SLT-treated eyes (Tables 2 and 3).
Table 2: Mean Intraocular Pressure (mmHg) SLT-Treated Eyes and Fellow Eyes (N=120)
SLT-Treated Eyes
Fellow Eyes (Untreated)
(mean, S.D.)
(mean, S.D.)
Baseline 25.3 mmHg (2.9) 21.4 mmHg (4.1)
Day 1 18.2 mmHg (4.4) 20.6 mmHg (4.7)
Week 26 20.9 mmHg (3.6) 19.5 mmHg (4.9)
Examination of mean IOP reduction, expressed in mmHg and as a percent of the baseline intraocular
pressure, serves to further emphasize the significant improvement in intraocular pressure in the SLTtreated
eyes. In contrast, fellow eyes experienced only a small decrease in IOP over the course of the
study.
Table 3: Intraocular Pressure Reduction (mmHg) SLT-Treated Eyes and Fellow Eyes (N=120)
SLT-Treated Eyes
Fellow Eyes (Untreated)
(mean, S.D.)
(mean, S.D.)
Day 1 7.1 mmHg (27.9%) 0.9 mmHg (3.5%)
Week 26 4.4 mmHg (17.1%) 1.9 mmHg (8.3%)
The decrease in intraocular pressure in the SLT-treated eyes was nearly 10-fold the decrease observed
in the untreated fellow eyes at Day 1, and twice as great as the decrease in fellow eyes at Week 26.
4.1.2.3 Safety
Primary measures of safety in this study included visual acuity, cup to disc ratio, results of anterior
segment examination, and adverse events. No changes were observed in either visual acuity or cup to
disc ratio from baseline to 26 weeks. Anterior segment findings included minimal cells and flare in
the SLT-treated eyes on postoperative Day 1. A mean score of 1, on a scale of 0 to 4, was reported for
the first two hours following SLT. This had decreased to a mean of 0.3 on the first postoperative day,
and had resolved by one week. Mean flare was 0.2, and no further cells or flare were noted for the
remainder of the study. Thus, cells and flare were minimal, and limited to the immediate postoperative
period. It should be noted that even though the presence of cells and flare in the anterior chamber is
expected following laser treatment of the trabecular meshwork, all observations of cells and flare were
reported by the study investigators as adverse events.
4.0 | Supportive Information — Clinical Experience with SLT
15

164.0 | Supportive Information — Clinical Experience with SL T
An increase in IOP of ≥ 10 mmHg above the baseline intraocular pressure was reported in 9 (7.5%)
of the SLT-treated eyes. This was considered likely to have been related to the study treatment (SLT)
in 7 of the 9 eyes. In 5 of these patients, the increase in IOP occurred within the first 24 hours following
SLT, and resolved within 1 day. In the other two patients, the increase in IOP occurred within
1 week of treatment and resolved within 2 weeks. In one case, a later occurrence of increased IOP
required surgical intervention (trabeculectomy), however this was considered by the study investigator
to be unrelated to SLT treatment. It should be noted that study patients were not pretreated with
apraclonidine 1%, even though this is the current standard of care for patients undergoing ALT,
with the goal of avoiding a laser-induced pressure spike.
Other reported complications that were considered to be related to treatment included conjunctivitis,
eye pain, blurred vision, iritis, corneal edema, corneal lesion, and headache.
4.1.3 Summary and Conclusions
In this prospective, multicenter clinical trial, 120 patients with uncontrolled open-angle glaucoma
were successfully treated with Selective Laser Trabeculoplasty, as an alternative to argon laser trabeculoplasty
(ALT). Significant reduction in intraocular pressure was observed in the SLT-treated eyes over
the course of the 26-week follow-up, and the safety profile was consistent with that reported for ALT. 4,5
The protocol for this clinical trial of SLT described use of a historical control ALT population, derived
from the published literature on results of ALT. However, the historical control developed for use as a
comparator against SLT proved to be invalid for several critical reasons. First, the historical control
population proved not to be matched to the SLT study population with regard to prior glaucoma
treatment. In contrast to the study population, which consisted of patients with uncontrolled openangle
glaucoma who were on maximum tolerated medical drug therapy (Max Rx group) as well as
patients who had previously failed laser trabeculoplasty (PFLT group), the historical control population
included newly-diagnosed primary open-angle glaucoma. There was no attempt to match the
historical control population to the study population with respect to concomitant glaucoma medications.
Of even greater consequence, the historical control population excluded patients who had previously
failed laser treatment, a group that constituted over 50% of the patients in the SLT study, a
group that typically responds poorly to laser trabeculoplasty retreatment. And in some instances the
control group excluded results of ALT failures, further biasing the derived IOP mean. In addition to
inadequate matching of baseline characteristics, the historical control population included patients
who underwent ALT performed on 360° of the trabecular meshwork, while SLT was limited to only
180° such that even the extent of treatment was not comparable for the two populations. Thus,
based on inadequate matching of the historical control population to the SLT population, use of this
population as a control was invalidated.

In summary, in this clinical trial of Selective Laser Trabeculoplasty, the intraocular pressure-reducing
effect of SLT was demonstrated in a population of glaucoma patients, with a safety profile similar to
that of ALT.
4.2 A Prospective, Randomized, Clinical Trial Comparing the Efficacy of Selective Laser
Trabeculoplasty (SLT) to Argon Laser Trabeculoplasty (ALT)
4.2.1 Methods
In this prospective clinical trial, patients with uncontrolled open-angle glaucoma (OAG), including
primary, pigmentary and pseudoexfoliative forms of OAG, were recruited from two glaucoma practices
located in Ottawa, Canada (K. Damji, M.D., University of Ottawa; W. Rock, M.D., private practice,
Ottawa). After being screened for eligibility, 77 patients were randomly assigned to undergo either
Selective Laser Trabeculoplasty (SLT) or Argon Laser Trabeculoplasty (ALT), performed at the
University of Ottawa by one of these two investigators. The inferior 180° of the angle was generally
treated, unless the patient had previously undergone ALT, in which case the superior 180° was treated
with the randomly assigned laser treatment, i.e., SLT or ALT. Following the laser procedure, patients
were examined at one hour, to assess intraocular pressure and anterior chamber reaction, and then at
1 week, and 1, 3, and 6 months.
4.2.2 Results
4.2.2.1 Demographics and Baseline Characteristics
Demographic information as well as information on diagnosis and baseline intraocular pressure are
shown in Table 4 for the total study population of 77 patients.
The study groups were very similar with regard to age and sex, and the majority (approximately
60%) had an initial diagnosis of primary open-angle glaucoma. The SLT treatment group had a history
of more drug use, with a mean of 3.6 glaucoma medications utilized as compared to 2.9 medications
in the ALT group (p=0.04). Baseline intraocular pressure was identical for the two groups, at 23.6 mmHg.
4.0 | Supportive Information — Clinical Experience with SLT
17

184.0 | Supportive Information — Clinical Experience with SL T
Table: 4 Demographic and Baseline Characteristics by Treatment Group
ALT Group
SLT Group
Characteristic (n=42) (n=35)
Age (years) 70.1 (10.2) 66.2 (10.4)
Sex (% female) 50.0 (21/42) 51.4 (18/35)
Diagnosis
Primary open-angle 59.5 (25/42) 57.1 (20/35)
Pseudoexfoliative 28.6 (12/42) 20.0 (7/35)
Pigmentary 2.4 (1/42) 8.6 (3/35)
Other 9.5 (4/42) 14.3 (5/35)
No. of Glaucoma Medications 2.9 (1.4) 3.6 (1.9)
IOP (mm Hg) 23.6 (3.5) 23.6 (4.1)
4.2.2.2 Intraocular Pressure Reduction
As shown in Table 5, a comparison of mean IOP values between ALT and SLT-treated groups at each
time point, unadjusted for the preoperative IOP level, revealed no differences between groups at any
of the time points from preoperative to Month 6. Baseline mean intraocular pressure was identical for
the two groups (23.6 mmHg), and remained similar over the 6-month follow-up period (18 mmHg
at 6 months).
Table 5: Mean Intraocular Pressure (mmHg) by Treatment Group and Time
ALT Group
SLT Group
Time N Mean (S.D.) N Mean (S.D.)
Baseline 42 23.6 (3.5) 35 23.6 (4.1)
Day 7 39 20.1 (5.1) 32 21.3 (5.0)
Month 1 38 19.7 (4.3) 33 20.6 (4.7)
Month 3 35 20.2 (5.4) 32 20.1 (5.2)
Month 6 34 18.3 (4.8) 30 18.0 (4.6)
Mean reduction in IOP from the preoperative examination to post-treatment timepoints for the overall
study group is shown in Table 6. As for mean intraocular pressure, no significant differences were
observed between ALT and SLT-treated groups at any of the postoperative times. By Month 6, the
average IOP reduction in both groups was at or above 5.0 mmHg.

Table 6: Mean Intraocular Pressure Reduction (mmHg) from the Preoperative Examination by
Treatment Group and Time
ALT Group
SLT Group
Time N Mean (S.D.) N Mean (S.D.)
Day 7 39 3.7 (4.8) 32 2.2 (5.2)
Month 1 38 4.0 (4.4) 33 3.1 (5.0)
Month 3 35 3.2 (5.1) 32 3.1 (5.1)
Month 6 34 5.0 (5.2) 30 5.2 (3.9)
Percentage reduction from baseline is shown for the overall study group in Table 7. Consistent with
the mean IOP reduction shown in Table 6, the mean percentage reduction in IOP from the preoperative
examination to post-treatment time points did not differ substantially between groups. By Month
6, percentage reductions in both ALT-treated and SLT-treated patients exceeded 20% from the preoperative
baseline value.
Table 7: Mean Intraocular Pressure Percentage Reduction from the Preoperative Examination by
Treatment Group and Time
ALT Group
SLT Group
Time N Mean (S.D.) N Mean (S.D.)
Day 7 39 15.1 (17.9) 32 8.1 (21.2)
Month 1 38 16.2 (16.9) 33 12.0 (18.6)
Month 3 35 13.2 (20.3) 32 13.0 (20.9)
Month 6 34 20.4 (20.5) 30 22.3 (16.0)
Intraocular pressure in untreated fellow eyes was followed in a subgroup of patients who had previously
failed laser treatment (PFLT subgroup), and is summarized in Table 8. In fellow eyes of patients
in the ALT treatment group, a decrease was observed in mean IOP from baseline to Month 1, after
which IOP remained largely unchanged through Month 6. In the SLT treatment group, IOP in fellow
eyes remained fairly constant through the course of the 6-month follow-up.
4.0 | Supportive Information – Clinical Experience with SLT
19

204.0 | Supportive Information — Clinical Experience with SL T
Table 8: Mean Intraocular Pressure in Untreated Fellow Eyes of the PFLT Subgroup by Treatment Group
and Time
ALT Group
SLT Group
Time N Mean (SD) N Mean (SD)
Baseline 17 21.4 (4.7) 10 17.9 (3.8)
Month 1 16 17.5 (5.2) 10 17.4 (3.4)
Month 3 12 18.5 (4.5) 9 16.2 (3.2)
Month 6 16 16.8 (4.1) 9 16.4 (2.9)
4.2.2.3 Safety
Inflammatory changes (grading of anterior chamber cells and flare) at one hour and one week after
laser treatment are shown in Table 9 or the total study population. One hour after SLT, there were
significantly more cells in the anterior chamber than were reported for the ALT-treated group. A grading
of 2+ or more was observed in 42.3% (n=11) of the SLT-treated group, versus 14.7% (n=5) of the
ALT-treated group (P=0.02, Chi-square test). However, by one week after laser treatment, and continuing
through the duration of follow-up, both treatment groups were essentially free of any signs of
cells and flare in the anterior chamber.
Table 9: Inflammatory Changes at One Hour and One Week Post-Treatment by Treatment Group and Time
One Hour after Laser Treatment:
Grading of Cells at One Hour
N Zero One Two Three
ALT 34 35.3 (12) 50.0 (17) 14.7 (5) 0.0 (0)
SLT 26 11.5 (3) 46.2 (12) 26.9 (7) 15.4 (4)
Grading of Flare at One Hour
N Zero One Two Three
ALT 33 45.5 (15) 45.5 (15) 9.1 (3) 0.0 (0)
SLT 26 26.9 (7) 57.7 (15) 15.4 (4) 0.0 (0)

One Week after Laser Treatment:
Grading of Cells at One Week
N Zero One Two Three
ALT 32 100.0 (32) 0.0 (0) 0.0 (0) 0.0 (0)
SLT 26 100.0 (26) 0.0 (0) 0.0 (0) 0.0 (0)
Grading of Flare at One Week
N Zero One Two Three
ALT 32 100.0 (32) 0.0 (0) 0.0 (0) 0.0 (0)
SLT 25 96.0 (24) 4.0 (1) 0.0 (0) 0.0 (0)
No serious or unanticipated adverse device effects were reported during this study. As a result of
standard pretreatment with apraclonidine 1%, to prevent increases in intraocular pressure, two
patients in each treatment group experienced an IOP spike of 5 mmHg or greater in the immediate
post-treatment period, and there were no reports of peripheral anterior synechia.
4.2.3 Summary and Conclusions
In this randomized clinical trial of the effect of ALT and SLT on IOP reduction in patients with
uncontrolled open-angle glaucoma, no overall treatment differences were observed at any postoperative
time point through 6 months after the laser procedure. IOP reduction from the preoperative
examination was comparable in both groups, and exceeded 5 mmHg by 6 months after surgery. The
percentage reduction in IOP was also comparable in both groups, with a greater than 20% reduction
from baseline IOP at 6 months after surgery.
An increased inflammatory response was observed following SLT, with a significantly higher grade for
anterior chamber cells at one-hour post-laser procedure than was reported for ALT. However, from
one week post-treatment through the 6-month examination, the two groups were essentially free of
any signs of cells or flare in the anterior chamber. No patients in the study developed peripheral
anterior synechiae, and there were no complications or adverse events.
These findings demonstrate that treatment with SLT results in a clinically substantial reduction in
IOP 6 months after treatment, with a magnitude of IOP reduction in SLT treated eyes similar to that
observed in ALT treated eyes.
4.3 Summary of Clinical Experience with SLT
4.0 | Supportive Information — Clinical Experience with SLT
Clinical evaluation of SLT in over 1,100 eyes worldwide serves to establish the safety and effectiveness
of this procedure as an alternative to ALT. Reduction of intraocular pressure following SLT in each of
the studies reported was very similar to the decrease in IOP reported for ALT. This was consistent
across studies in which there was a concurrent ALT control, as well as with the extensive body of
21

4.0 | Supportive Information — Clinical Experience with SLT
published data on ALT, demonstrating the comparable effects of both of these laser trabeculoplasty
procedures.
Safety outcomes following SLT were also consistent with the published safety data on ALT, with
regard to all major safety parameters, including acute intraocular pressure increase and anterior
chamber inflammation. Transient elevation of IOP was reported in 7% to 25% of eyes following SLT,
varying by study and patient population. This compares favorably with published reports showing an
increase in IOP of 5 mmHg or more in up to 33% of eyes, and an increase of some magnitude in up
to 70% of eyes following ALT. 43-45 This prevalence of IOP rise following argon laser trabeculoplasty led
to evaluation, and adoption of apraclonidine, administered one hour prior to treatment, as a standard
of care in this patient population. 46 Published reports on anterior chamber reaction (cell and flare) are
also consistent with the clinical data reported for SLT. 43
In summary, the extensive body of clinical data on selective laser trabeculoplasty serves to support
both the safety and effectiveness of this procedure, as well as the substantial equivalence of SLT to ALT.
22

Ophthalmic lasers for use in laser trabeculoplasty are Class II devices, classified as per CFR 886.4390
(product code HQF – laser, ophthalmic) and CFR 878.4810 (product code GEX – laser surgical
instrument). Additionally, under CFR 886.4392, Nd:YAG lasers are identified as mode-locked or
Q-switched solid state lasers which generate short pulse, low energy, high power radiation.
The Coherent Selecta 7000 is substantially equivalent to commercially available lasers with regard to
indication for use and system characteristics, as follows:
- K913127 – Coherent Novus 3000 Argon Photocoagulator
- K972514 – Laserex LP1532 Nd:YAG Photocoagulator
- K962592 – Alcon Ophthalas 532 Solid State Photocoagulator
- K900199 – Lasag Microruptor 2 Nd:YAG Ophthalmic Laser
Like the Coherent Selecta 7000, these predicate devices are indicated for use in laser trabeculoplasty,
performed in patients with open-angle glaucoma. Additionally, the system characteristics of the
Coherent Selecta 7000 and the predicate lasers are very similar, as shown in the table of technological
comparison on the following page. With the exception of the Coherent Novus 3000 Argon
Photocoagulator, the three other laser predicate devices utilize a Nd:YAG laser source and the Laserex
and Alcon lasers emit at the same wavelength, i.e., 532 nm, as the Coherent Selecta 7000. The
Coherent Selecta 7000 and the predicate lasers employ a diode or HeNe aiming beam.
The shorter pulse duration (i.e., 3 nanoseconds) of the Coherent Selecta 7000 is integral to the mechanism
of selective targeting of pigmented trabecular meshwork cells, since this pulse duration is less
than the thermal relaxation time of 1 microsecond for melanin. Pulses with duration of less than 1
microsecond deposit energy within the target cells more rapidly than this energy can diffuse away.
While the temperature within the target, i.e., pigmented trabecular meshwork cells, increases to levels
adequate to cause selective cellular destruction, thermal diffusion to surrounding non-pigmented cells
is minimized. Preclinical investigations in cultures of trabecular meshwork cells and in trabecular
meshwork obtained from human eye bank eyes substantiated this mechanism of selective targeting of
cells. Following SLT, changes in cellular ultrastructure were limited to pigmented trabecular meshwork
cells, while adjacent non-pigmented cells and tissues were spared. This was in contrast to the
tissue exposed to ALT, in which non-specific destruction of trabecular meshwork cells, and thermal
damage to underlying and adjacent collagen beams were observed. These changes may cause or contribute
to the elevated post-treatment intraocular pressure observed following ALT, and to the limited
success of ALT retreatment. On this basis, it can be concluded that the shorter pulse duration and
low energy of the Coherent Selecta 7000 are associated with less tissue damage than the predicate
devices when used to perform laser trabeculoplasty. The Coherent Selecta 7000 thus offers an
improved safety profile as compared to the predicate devices by providing greater protection to the
trabecular meshwork and preserving this tissue for the possibility of additional medical, laser or surgical
treatment. This is supported by clinical data demonstrating a similar effect of SLT and ALT on
reduction of intraocular pressure and on patient safety.
5.0 | Premarket Notification for the Selecta 7000 Laser
23

245.0
| Premarket Notification for the Selecta 7000 Laser
Comparison of Coherent Selecta 7000 and Predicate Devices
Coherent Selecta 7000 Coherent Novus 3000 Laserex LP1532 Alcon Ophthalas 532 Lasag Microruptor 2
Nd:YAG Ophthalmic Laser Argon Ophthalmic Laser Nd:YAG Photocoagulator Solid State Photocoagulator Nd:YAG Ophthalmic Laser
K913127 K972514 K962592 K900199
Indications for Use Indicated for use in laser Indicated for use in the Indicated for use in laser Indicated for use in laser g
Indicated for performing
trabeculoplasty treatment of ocular trabeculoplasty trabeculoplasty the trabeculoplasty
pathology including
trabeculoplasty in
Power/Energy 0.1–2.0 mJ 50–1750 mW 30 mW–2000 mW 50 mW–3000 mW 0.3–15.0 J
Pulse Duration 3 ns 0.01–1.0 sec 0.01–2.0 sec 0.01–2.0 sec, and continuous 20 msec
Laser Media Nd:YAG Argon Nd:YAG Nd:YAG Nd:YAG
Wavelength 532 nm 488–514 nm (blue-green) 532 nm 532 nm 1064 nm
Mode of Operation Q-Switched CW Q-switched CW
procedure in patients with
uncontrolled open-angle
open-angle glaucoma
Spot Size 400 µm 50–1000 µm 50–500 µm 50–1000 µm 70 µm
Aiming Beam Diode, variable intensity Diode, variable intensity Diode, variable intensity HeNe, four intensities HeNe, maximum intensity
from barely visible to from barely visible to from 0.05–0.95 mW selectable up to 1mW of 0.1 mW
< 1.0 mW 1.5mW
Laser Control System Microprocessor Microprocessor Microprocessor Microprocessor Microprocessor
Cooling System Air cooled Air cooled Air cooled Internal water cooled Air cooled
Slit Lamp Coherent LDS-10C Slit Lamp Coherent, Zeiss, Haag Streit Zeiss, Haag Streit Zeiss, Haag Streit Zeiss
Dimensions Table: 94 cm x 58 cm 47 cm x 20 cm x 60 cm 19 cm x 31 cm x 51 cm 80 cm x 36 cm x 81 cm
(37″ x 23″) (18.5″ x 8″ x 24″) (7.5″ x 12″ x 20″) (31.5″ x 14″ x 32″)
Height: 152 cm (h x w x d) (h x w x d) (h x w x d,
(60″) laser console only)
Weight 123 kg (270 lbs) 30 kg (65 lbs) 17 kg (37 lbs) 99 kg (218 lbs) 350 kg (772 lbs)
Electrical 115/230 VAC; 50/60 Hz; 100–120 VAC; 15–20 A 100–120 VAC, 220 VAC, 16 A, 50–60 Hz 240/220/210 V
Requirements 4/2 A 220–240 VAC; 10 A 220–250 VAC 120/110/100 V
50/60 Hz single phase, 50/60 Hz 50/60 Hz, 10/20 A

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26
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Acknowledgements: Authored by Karen Baker, Senior Manager, Regulatory Affairs,
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Reviewed by Jorge Alvarado, M.D., University of California at
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Printed in U.S.A. M10524012.5M
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Nd:YAG LASER: Laser Class 3B/IIIb
MAX OUTPUT: 532 nm, 5 mJ, 3 ns pulse
DIODE LASER: Laser Class 2/II
MAX OUTPUT: 635 nm,