[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9373-9377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5445]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. 93P-0277]


Ophthalmic Devices; Reclassification of Neodymium:Yttrium: 
Aluminum:Garnet (Nd:YAG) Laser for Peripheral Iridotomy

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notice of panel recommendation.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the ophthalmic neodymium:yttrium:aluminum:garnet (Nd:YAG) 
laser (mode-locked or Q-switched) intended for peripheral iridotomy 
from class III (premarket approval) into class II (special controls). 
The agency is also issuing for public comment the recommendation of the 
Ophthalmic Devices Panel (the Panel) regarding the reclassification of 
this device. The Panel made this recommendation after reviewing the 
reclassification petition submitted by Intelligent Surgical Lasers, 
Inc. (ISL). FDA is also issuing for public comment its tentative 
findings on the Panel's recommendation and its intent to change the 
generic designation of the device from Nd:YAG laser for posterior 
capsulotomy to Nd:YAG laser for posterior capsulotomy and peripheral 
iridotomy. After considering any public comments on the Panel's 
recommendation and FDA's tentative findings, FDA will approve or deny 
the reclassification petition by order in the form of a letter to the 
petitioner. FDA's decision on the petition will be announced in the 
Federal Register. If the petition is approved and the device is 
reclassified into class II, FDA will publish a final rule to codify the 
reclassification.

DATES: Written comments by June 6, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Morris Waxler, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, -301-594-2018.

SUPPLEMENTARY INFORMATION:

I. Introduction

    On March 2, 1993, ISL submitted a petition under section 513(f)(2) 
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360c(f)(2)), requesting that the ophthalmic Nd:YAG laser (mode-locked 
or Q-switched) intended for peripheral iridotomy be reclassified from 
class III into class II.
    The subject device is automatically classified into class III under 
section 513(f)(1) of the act because it is not within a type of device 
that was introduced or delivered for introduction into interstate 
commerce for commercial distribution before May 28, 1976, it is not 
substantially equivalent to such a device, and it is not substantially 
equivalent to a device placed in commercial distribution since May 28, 
1976, which was subsequently reclassified into class II or class I.
    Section 513(f)(2) of the act provides that FDA may initiate the 
reclassification of a device classified into class III under section 
513(f)(1) of the act, or the manufacturer or importer of the device may 
petition the agency to reclassify the device into class I or class II. 
FDA's regulations in 21 CFR 860.134 set forth the procedures for filing 
and review of a petition to reclassify these class III devices. In 
order to reclassify the ophthalmic Nd:YAG laser (mode-locked or Q-
switched) for peripheral iridotomy into class II, it is necessary that 
the proposed new class has sufficient regulatory controls to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use.

II. Background

    Nd:YAG lasers originally were developed for industrial 
applications, and were successfully employed in such industries as 
watchmaking prior to the initiation of clinical trials in Europe and 
the United States. Therefore, the basic principles of operation of the 
device 

[[Page 9374]]
were scientifically established well before any clinical testing of the 
device in ophthalmic surgery. -
    Surgical iridectomies, i.e., manual surgical excisions of part of 
the iris, were performed, with mixed results, in the late 1800's to 
relieve the symptoms of glaucoma. In 1920, the differences between the 
various types of glaucoma were described and it then became apparent 
why the surgery relieved the symptoms of some patients and not others. 
As a result, peripheral surgical iridectomies were then performed only 
on patients with pupillary-block (angle-closure) glaucoma.
    Argon laser iridotomies, surgery with an argon laser to create an 
iris hole, became the preferred treatment for most cases of angle-
closure glaucoma in the 1970's. Although there were advantages to the 
use of argon lasers (reduced risk of flat chamber, wound leak, 
endophthalmitis, malignant glaucoma, and lens subluxation), there were 
different complications associated with the new modality (permanent 
corneal burns, retinal burns, iritis, localized cataract formation, 
posterior synechiae, failed patency, intraocular pressure (IOP) rises 
and iris pigmentation).
    The next treatment modality, iridotomy with the Q-switched Nd:YAG 
laser, was introduced during the early 1980's to treat angle-closure by 
a mechanical cutting effect to create peripheral iridotomies rather 
than the thermal effect of argon lasers. Because the technology 
permitted tissue disruption through a transparent medium with 
negligible heat generation, the Nd:YAG laser appeared to be ideal for 
ophthalmic surgery on opacified posterior capsular membranes, thus 
avoiding the risks involved in traditional invasive surgery as well as 
the thermal effects characteristic of other ophthalmic laser devices. 
Clinical trials were conducted and, subsequently, FDA granted premarket 
approval for three CooperVision Nd:YAG lasers (models 2000 and 2500 in 
1985; model 2300 in 1986) for discission of the posterior capsule of 
the eye (posterior capsulotomy).
    On January 24, 1986, the Medical Laser Manufacturers Association 
(MLMA) submitted to FDA, under section 513(e) of the act and 21 CFR 
860.120, a petition for a change in the classification of the 
ophthalmic Nd:YAG laser (mode-locked or Q-switched) intended for 
posterior capsulotomy. On February 20, 1986, the MLMA amended its 
petition to include section 513(f)(2) of the act and 21 CFR 860.134 of 
the regulations as a basis for its requested relief. The petition 
requested that the ophthalmic Nd:YAG laser (mode-locked or Q-switched), 
intended for posterior capsulotomy, be reclassified from class III into 
class II. FDA referred the petition to the Panel for its recommendation 
as to whether the device should be reclassified. On May 22, 1986, 
during an open public meeting the Panel recommended that FDA reclassify 
the device from class III into class II when intended for use in 
posterior capsulotomy. The Panel identified the following devices as 
examples of the generic type of device: The Meditec OPL-3, the M-Tec 
2000, the Horizon 2000, the Horizon 2500, and the YAG-100.
    The Panel also recommended that this generic type of device be 
identified as the ``Nd:YAG laser for posterior capsulotomy.'' On 
December 14, 1987 (52 FR 47454), FDA published in the Federal Register 
a notice announcing the Panel's recommendation. On March 31, 1988, FDA 
ordered (by letter to MLMA) the reclassification of the Nd:YAG laser 
intended for posterior capsulotomy and substantially equivalent devices 
of this generic type from class III into class II.
    On March 2, 1993, ISL submitted to FDA, under section 513(f) of the 
act, a petition requesting reclassification of the ophthalmic Nd:YAG 
laser (mode-locked or Q-switched) intended for peripheral iridotomy 
from class III into class II (Ref. 1). The agency referred the petition 
to the Panel for its recommendation on the requested change in 
classification.

III. Recommendation of the Panel

    The Panel met on October 28, 1993, in an open public meeting to 
discuss the subject device. After considering the published studies, 
published data on laser parameters for safe and effective Nd:YAG 
iridotomy, and the guidelines for laser iridotomy published by the 
American Academy of Ophthalmology (Ref. 2), the Panel recommended that 
the ophthalmic Nd:YAG laser (mode-locked or Q-switched) intended for 
peripheral iridotomy be reclassified from class III into class II. The 
Panel believed the petitioners had presented sufficient data to 
demonstrate that special controls can be established to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use. The Panel also noted that the procedure is well 
understood and widely used by most ophthalmologists in the United 
States, as evidenced by the discussion of the Panel members (Ref. 3 p. 
83).

IV. Device Description

    The ophthalmic Nd:YAG laser intended for peripheral iridotomy 
consists of a mode-locked or Q-switched solid state Nd:YAG laser that 
generates short pulse, low energy, high power, coherent optical 
radiation. When the laser output is combined with focusing optics, the 
high irradiance at the target site causes tissue disruption via optical 
breakdown. A visible aiming system is utilized to target the invisible 
Nd:YAG laser radiation on or in close proximity to the target tissue.

A. Principles of Operation

    The Nd:YAG laser is one component of a device system that also 
includes conditioning optics, a delivery system, an aiming system, and 
operator controls. Its laser beam must be shaped by conditioning optics 
to a configuration with a specific profile and desired characteristics. 
The physical properties of the Nd:YAG laser beam that directly 
influence the ability of the device to perform its intended function 
safely and effectively are its invisible infrared beam at a wavelength 
of 1,064 nanometers, output pulse generating method, output energy, 
pulse width, spatial mode, convergence angle, spotsize, and pulse 
repetition frequency. The only variable that is selected by the 
ophthalmic surgeon during the iridotomy procedure is the device's 
output energy.
    While other types of lasers (e.g., the argon laser) used for 
ophthalmic surgery employ long duration exposures to achieve thermal 
tissue effects for photocoagulation, tissue cutting, or tissue 
destruction, the ophthalmic Nd:YAG laser (mode-locked or Q-switched) 
intended for peripheral iridotomy uses very short duration exposures 
(pulses) that are focused precisely to small spot sizes and that 
produce a high local irradiance (power density). The combination of 
short exposure duration and high irradiance results in nonlinear 
absorption of the radiation by the target tissue, causing tissue 
disruption through optical breakdown. The plasma generated by the 
process of optical breakdown provides protection for posterior tissue 
in direct line with the incident beam. These unique characteristics 
permit the ophthalmic Nd:YAG laser to perform a patent iridotomy with 
reduced inflammation, regardless of iris pigmentation.

B. Device Specifications

    Mode-locked laser output consists of a train of 7 to 10 pulses with 
a pulse duration of about 30 nanoseconds and a pulsewidth of about 30 
picoseconds. Q-switched laser output consists of single pulses, with 
pulsewidths of about 2 to 20 nanoseconds in duration.

[[Page 9375]]

    The typical threshold of optical breakdown of tissue in air for 
mode-locked lasers is 1014 watts per centimeter squared, and for 
Q-switched lasers is 1011 watts per centimeter squared. The 
threshold for optical breakdown of tissue in an aqueous environment 
appears to be lower but varies depending upon the nature of the tissue. 
For disruption of the iris of the eye, an energy setting of 4.0 to 6.0 
millijoules results in optical breakdown creating the desired tissue 
effect after application of 1 to 4 bursts that contain 1 to 4 pulses/
burst (Refs. 10, 11, 12, 13, 14, and 15).
    In addition to the laser, the other two main components of the 
system subject to the petition are a visible light beam aiming system 
and a slit-lamp biomicroscope used by the operator to target the 
treatment laser beam and to visually monitor the treatment process.

V. Summary of Reasons for the Recommendation

    The Panel based its recommendation on the data and information 
contained in the petition and presented during the open committee 
discussion during the Panel meeting on October 28, 1993. After review 
and consideration of the available information, the Panel gave the 
following reasons in support of its recommendation to reclassify the 
generic type ophthalmic Nd:YAG laser (mode-locked or Q-switched) 
intended for peripheral iridotomy from class III into class II:
    (1) The device is not an implant.
    (2) General controls by themselves are insufficient to provide 
reasonable assurance of the safety and effectiveness of the device.
    (3) There is sufficient publicly available information to establish 
special controls to assure the performance of the device for its 
intended use. Also, there is sufficient publicly available information 
to demonstrate that the risks to health have been determined, and that 
the relationship between the device's performance parameters and risks 
and its safety and effectiveness have been established by valid 
scientific evidence.
    (4) Various safety features of medical lasers are already 
controlled by existing FDA standards (21 CFR 1040.10 and 1040.11) 
promulgated under the Radiation Control for Health and Safety Act of 
1968 (42 U.S.C. 263b).
    The Panel believed that the following devices identified in the 
petition are representative of the generic type of device: the NIDEK 
YAG-100; the NIDEK 200; the Coherent 9900; and the Meridian LASAG MR-2.

VI. Risks To Health

    Based on publicly available information establishing that it can 
successfully perform a discission of the iris (iridotomy), the Panel 
concluded that the ophthalmic Nd:YAG laser (mode-locked or Q-switched) 
intended for peripheral iridotomy is effective for its intended use. 
The Panel also determined that the foreseeable risks to health 
associated with the device are related to either unintentional damage 
to nontarget tissue or postoperative complications resulting from user 
error or device malfunction. These risks include corneal damage or 
edema, iritis, corectopia, lenticular opacities, retinal damage, 
transient elevation of IOP, failure to obtain iridotomy, precipitation 
of angle-closure attack, late closure of iridotomy, and iris atrophy. 
The risks of these adverse effects have been documented to be low and 
acceptable when the device is used in accordance with its directions 
and appropriate postoperative care is followed.
    The use of the Nd:YAG laser for peripheral iridotomy may be 
contraindicated for patients without a clear cornea or aqueous, 
patients with chronic uveitis, patients with a tendency to bleed, 
patients on anticoagulant therapy, and patients with a glass 
intraocular lens.

VII. Summary of Data Upon Which the Recommendation is Based

    During its review and discussion of the petition, the Panel paid 
close attention to the risks associated with the use of the device. The 
clinical studies included in the petition reported few risks to health, 
and the few that were reported were clearly identified. The Panel 
concluded that special controls can be established to provide 
reasonable assurance of the safety and effectiveness of the device when 
intended for peripheral iridotomy. The incidence rates of iridotomy 
closure, vision loss due to progression of laser induced lens or 
corneal damage, additional filtration surgery, transient iris bleeding, 
transient IOP spike, focal lens opacities, nonprogressive corneal 
endothelial changes, retinal damage, focal corneal opacities, mild 
iritis, and hyphema associated with Nd:YAG laser iridotomy are either 
lower than those for argon laser surgery or conventional surgical 
iridotomy or are self-limiting and not persistent.
    Del Priore, et al. (Ref. 4) compared iridotomies using the Nd:YAG 
laser and argon laser in a prospective, randomized clinical study. The 
study focused on 43 patients (86 eyes) followed for 20 months (mean 
followup time 27 7 months). The mean preoperative visual 
acuity in the argon treated and the Nd:YAG treated eyes was 6/12 
3 Snellen lines and did not change postoperatively. No 
retinal detachments or laser burns of the macula were detected. 
Iridotomy closure was not observed in any of the Nd:YAG laser treated 
eyes, but 9 (21 percent) argon iridotomies required retreatment. Visual 
loss due to progression of laser induced lens or corneal damage was not 
observed in any eye. Nine of 43 (21 percent) argon laser treated eyes 
and 8 of 43 (19 percent) Nd:YAG laser treated eyes required laser 
trabeculoplasty for further intraocular pressure lowering after 
iridotomy. Transient iris bleeding was encountered in 19 (44 percent) 
Nd:YAG laser treated eyes, but was not seen in any argon treated eyes. 
Six (32 percent) of the eyes with transient bleeding had IOP elevations 
greater than 10 millimeters (mm) Hg within the first 3 hours, and the 
IOP spike was greater than 20 mm Hg in four (17 percent) of these eyes. 
Focal opacification of the anterior lens capsule was seen in 23 (53 
percent) argon laser treated eyes and none of the Nd:YAG laser treated 
eyes. This difference is statistically significant (P<0.01). Focal 
corneal endothelial opacities were encountered in 13 (30 percent) 
Nd:YAG laser treated and 11 (26 percent) argon laser treated eyes. 
Neither type of opacity enlarged clinically, and both tended to 
regress. Clinically significant corneal edema or corneal decompensation 
did not develop in the eyes of either treatment group during long term 
followup. Although several different Nd:YAG lasers (AM YAG-100 
(American Medical Optics), Coherent JK Nd:YAG, and Coherent 9900) were 
used in the study, no differences were indicated by the results. The 
Nd:YAG laser offers intraoperative advantages in patients who cannot 
maintain a steady head position and fixation, and is independent of 
iris color. The Nd:YAG laser is also regarded as the treatment of 
choice in most patients with chronic pupillary-block glaucoma (Ref. 4).
    In other studies, Fleck, et al. (Ref. 5) compared Nd:YAG laser 
iridotomy with and without argon laser pretreatment and concluded that 
argon laser pretreatment offers no advantage over primary Nd:YAG laser 
iridotomy. On the other hand, Goins, et al. (Ref. 6) found that argon 
laser pretreatment significantly reduced the incidence of hemorrhage 
during Nd:YAG iridotomy (p=0.012). Robin and Pollack (Ref. 7) found 
that hyphema is not clinically significant when eyes are pretreated 
with the argon laser. Of the Nd:YAG 

[[Page 9376]]
iridotomies they studied, 67 percent (8/12) had operative hemorrhages, 
while 17 percent (2/12) of the argon pretreated eyes had hemorrhages. 
Robin and Pollack (Ref. 7) also reported a lower incidence of bleeding 
when eyes were pretreated with the argon laser. McGalliard and Wishart 
(Ref. 8) studied 81 eyes with shallow anterior chambers and raised IOP. 
Iridotomies were performed to prevent further angle closure glaucoma 
(ACG) and to remove pupillary block that could have contributed to the 
raised IOP. In eyes where there was no peripheral anterior synechia 
(PAS) there was no drop in IOP, but in eyes with well established PAS 
69 percent showed a drop in IOP. Jiang (Ref. 9) also found a very 
significant difference between the preoperative values and the 
postoperative values at 3-year followup. In a study of 31 patients (40 
eyes with persistent angle closure glaucoma (PACG)), the iridotomy 
controlled the IOP, and the iridotomy hole closed spontaneously in four 
eyes. The success rates were 94 percent at 6 months, 91 percent at 2 
years, and dropped to 82.4 percent at the end of the third year. 
Romano, et al. (Ref. 10) compared Nd:YAG iridotomy with conventional 
surgical iridectomy. They found that in the nonlaser-treated group, 
pilocarpine alone controlled the IOP. In the laser treated group, eyes 
without PAS required fewer medications to maintain normal pressures 
than eyes with PAS required.
    Regarding Nd:YAG laser technique, March (Ref. 11) recommends that a 
laser lens be used in performing a Nd:YAG laser iridectomy to aid in 
the placement of the lesion on the iris. He also recommends iridectomy 
placement beneath the upper lid if possible to avoid complications of 
halos, blurring, horizontal bands of light, and diplopia secondary to 
light transmission through the site postoperatively. Focusing on the 
ability of the Nd:YAG laser to produce a patent iridotomy, Spaeth (Ref. 
11) reviewed a prospective study of 58 patients in which the right eyes 
were treated with the LASAG Microruptor 2 Nd:YAG laser and the left 
eyes with a Britt argon laser, and concluded that the Nd:YAG laser can 
indeed produce a patent iridotomy. He observed that there was a 
significant pressure rise in one third of the cases treated and that 
frequent hemorrhage occurred at the time of the iridectomy, but was not 
so severe that a gross hyphema developed. In no instance of Nd:YAG 
laser treatment was corneal endothelium or anterior lens capsule damage 
noted. Completion of the iridectomy was made on the basis of 
visualization of the lens through a hole in the iris. The IOP results 
reported for both lasers indicated a rise in IOP at 1 hour 
postoperative which decreased to the preoperative level 1 week 
postoperative.
    In two studies by Robin and Pollack (Refs. 7 and 12) using the 
Coherent 9900 Q-switched and the AMO YAG-100 lasers, the authors 
reported that hyphema was not clinically significant and was consistent 
with other studies showing a lower incidence of bleeding for pretreated 
argon eyes. In one study, 33 eyes (both brown and blue irises) from 28 
patients with pupillary block glaucoma were treated. Study followup was 
1 month. Twenty-six had previous argon laser iridectomies. All had 
iridectomy closure within a week of argon treatment or there had been 
failure to penetrate the iris; the preoperative IOP range was 8 mm to 
74 mm Hg and was 10 mm to 43 mm Hg at 1-month followup. Complications 
reported after use of the Coherent 9900 Q-switched Nd:YAG laser were 
focal discrete nonprogressive corneal endothelial changes in six eyes 
(18 percent), bleeding in 12 eyes (36 percent), and IOP greater than 10 
mm Hg during the first 3 hours postoperatively in nine eyes (27 
percent). No hyphema, laser-induced lens damage or retinal damage was 
observed. Two iridectomies closed within days of treatment. Study 
followup was 1 month.
    In the second study, the authors studied 40 eyes (20 patients) in 
which one eye was treated with an argon laser and the fellow eye with a 
Q-switched YAG laser, an AMO YAG-100 (7 patients) or a Coherent JK 
prototype (13 patients). Iris colors were blue and brown. At no time 
was the IOP change significant between the argon laser and YAG laser 
treated patients. Inflammation was seen in all patients. Of the argon 
treated eyes, 12 had a rise in IOP during the first 3 hours 
postoperatively. Six (30 percent) iridectomies required retreatment, 
focal corneal opacities were seen in five (25 percent) of the argon 
treated eyes, and posterior synechiae were seen in three (15 percent) 
of the argon treated eyes. By comparison, thirteen YAG treated eyes had 
an IOP rise during the first 3 hours and bleeding occurred in nine (45 
percent), with one having less than 5 percent hyphema which cleared by 
the first postoperative day. No iridectomy closures were seen, while 
focal corneal opacities were seen in seven (35 percent) of the YAG 
treated eyes. None of the YAG treated eyes suffered focal lenticular 
opacity. Finally, the Panel noted the publication by the American 
Academy of Ophthalmology, Laser Peripheral Iridotomy for Pupillary-
Block Glaucoma (Ref. 2), which discusses surgical iridectomy and laser 
iridotomy techniques, treatment parameters, complications and patient 
care, and provides insight in addressing laser iridotomy and the above 
risks.
    The Panel believes that the risks identified above that are 
directly attributable to the Nd:YAG laser for peripheral iridotomy can 
be controlled by special controls. The risks of damage to the corneal 
endothelium, the lens, or the retina are slight. These risks can be 
minimized by ensuring proper device design of the laser beam for 
accuracy and precision. The risk of IOP rise can be controlled by 
proper device labeling and by the surgeon through available, 
established medical procedures and treatments. There is reasonable 
assurance that an ophthalmic Nd:YAG laser (mode-locked or Q-switched) 
is safe and effective for iridotomy when the device is used consistent 
with appropriate labeling, designed in accordance with proper device 
specifications and produced under a quality assurance program to ensure 
that critical specifications are met within specified tolerances.

VIII. FDA's Tentative Findings

    FDA tentatively concurs with the recommendation of the Panel that 
the Nd:YAG laser intended for peripheral iridotomy should be 
reclassified into class II and that the generic designation of the 
device be changed from Nd:YAG laser for posterior capsulotomy to Nd:YAG 
laser for posterior capsulotomy and peripheral iridotomy. The agency 
also tentatively concludes that ``new information'' in the form of 
publicly available, valid scientific evidence exists to provide 
reasonable assurance of the safety and effectiveness of the Nd:YAG 
laser for its intended use. Consistent with the purpose of the act, 
class II controls (labeling) as defined by section 513(a)(1)(B) of the 
act are sufficient to provide reasonable assurance that current Nd:YAG 
lasers are safe and effective for their intended use.

IX. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) that thisaction 
is of a type that does not individually or cumulatively have a 
significant effect of the human environment. Therefore, neither as 
environmental assessment nor an environmental impact statement is 
required.

[[Page 9377]]


X. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because reclassification of devices from class III 
into class II may relieve manufacturers of the cost of complying with 
the premarket approval requirements in section 515 of the act, and may 
permit small potential competitors to enter the marketplace by lowering 
their costs, the agency certifies that the final rule will not have a 
significant economic impact on a substantial number of small entities. 
Therefore, under the Regulatory Flexibility Act, no further analysis is 
required.

XI. Request for Comments

    Interested persons may, on or before June 6, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m. Monday through Friday.

XII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Reclassification Petition for the Nd:YAG Laser for Iridotomy, 
submitted by Intelligent Surgical Lasers, Inc., March 2, 1993.
    2. American Academy of Ophthalmology Guideline: Laser Peripheral 
Iridotomy for Pupillary-Block Glaucoma, Approved by Board of 
Directors, June 25, 1988. (Also contained in the petition.)
    3. Transcript of the Ophthalmic Devices Panel Meeting, October 
28, 1993.
    4. Del Priore, L. V., A. L. Robin, and I. P. Pollack, 
``Neodymium:YAG and Argon Laser Iridotomy: Long-term Followup in a 
Prospective, Randomized Clinical Trial,'' Ophthalmology, 94(9):1205-
1211, 1988.
    5. Fleck, B. W., E. Wright, C. McGlynn, ``Argon Laser 
Pretreatment 4 to 6 Weeks Before Nd:YAG Laser Iridotomy,'' 
Ophthalmic Surgery, 22(11):644-649, 1991.
    6. Goins, K., E. Schmeisser, T. Smith, ``Argon Laser in Nd:YAG 
Iridotomy,'' Ophthalmic Surgery, 21(7):497-500, 1990.
    7. Robin, A. L. and I. P. Pollack, ``Q-switched Neodymium-YAG 
Laser Iridotomy in Patients in Whom the Argon Laser Fails,'' 
Archives of Ophthalmology, 104(4):531-535, 1986.
    8. McGalliard, J. N., P. K. Wishart, ``The Effect of Nd:YAG 
Iridotomy on Intraocular Pressure in Hypertensive Eyes with Shallow 
Anterior Chambers,'' Eye, 4(6):823-829, 1990.
    9. Jiang, Y. Q., ``The Long-term Effect of Nd:YAG Laser 
Iridotomy,'' Chung-Hua Yn Ko Tsa Chih Chin, Journal of 
Ophthalmology, 27(4):221-224, 1991.
    10. Romano, J. H., R. A. Hitchings, and D. Pooinasawmy, ``Role 
of Nd:YAG Peripheral Iridectomy in the Management of Ocular 
Hypertension With a Narrow Angle,'' Ophthalmic Surgery, 19(11):814-
816, 1988.
    11. March, W. F., and G. Spaeth, ``YAG Laser Iridectomy, 
Complications,'' Ophthalmic Lasers (A Second Generation), Thorogare, 
New York: Slack Inc., 1990.
    12. Robin, A. L. and I. P. Pollack, ``A Comparison of 
Neodymium:YAG and Argon Laser Iridotomies,'' Ophthalmology, 
91(9):1011-1016, 1984.
    13. Moster, M. R., et al., ``Laser Iridectomy, A Controlled 
Study Comparing Argon and Neodymium:YAG,'' Ophthalmology, 93:20-24, 
1986.
    14. Cinotti, D. J., et al., ``Neodymium:YAG Laser Therapy for 
Pseudophakic Pupillary Block,'' Journal of Cataract and Refractive 
Surgery, 12:174-179, 1986.
    15. Robin, A. L. et al, ``Q-switched Neodymium-YAG Iridotomy: A 
Field Trial with a Portable Laser System,'' Archives of 
Ophthalmology, 104:526-530, 1986.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 886 be amended as follows:

PART 886--OPHTHALMIC DEVICES

    1. The authority citation for 21 CFR part 886 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    2. Section 886.4392 is amended by revising the section heading and 
paragraph (a) to read as follows:


Sec. 886.4392  Nd:YAG laser for posterior capsulotomy and peripheral-
iridotomy.

    (a) Identification. The Nd:YAG laser for posterior capsulotomy and 
peripheral iridotomy consists of a mode-locked or Q-switched solid 
state Nd:YAG laser intended for disruption of the posterior capsule or 
the iris via optical breakdown. The Nd:YAG laser generates short pulse, 
low energy, high power, coherent optical radiation. When the laser 
output is combined with focusing optics, the high irradiance at the 
target causes tissue disruption via optical breakdown. A visible aiming 
system is utilized to target the invisible Nd:YAG laser radiation on or 
in close proximity to the target tissue.
 * * * * *

    Dated: February 14, 1996.
 D.B. Burlington,
 Director, Center for Devices and Radiological Health.
[FR Doc. 96-5445 Filed 3-7-96; 8:45 am]
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