SL990, SL980, SL950

K992836 · Cso · HJO · Nov 9, 1999 · Ophthalmic

Device Facts

• Record ID: K992836
• Device Name: SL990, SL980, SL950
• Applicant: Cso
• Product Code: HJO · Ophthalmic
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

An AC-powered slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment

Device Story

The AC-powered slit lamp biomicroscope is an ophthalmic diagnostic instrument used by eye care professionals in clinical settings. It utilizes a high-intensity light source focused into a thin, adjustable slit to illuminate the anterior segment of the eye. The clinician observes the eye through a binocular microscope, allowing for detailed examination of the cornea, iris, lens, and anterior chamber. By manipulating the slit width, angle, and magnification, the practitioner can identify structural abnormalities, pathologies, or trauma. The device provides visual magnification to assist in clinical decision-making regarding ocular health and treatment planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

AC-powered slit lamp biomicroscope; optical magnification system; adjustable slit illumination source; binocular viewing assembly. No software or digital processing components described.

Indications for Use

Indicated for eye examination of the anterior eye segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or trauma affecting structural properties of the anterior eye segment in patients requiring ophthalmic evaluation.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 1999

Mr. R. Brent Miner CSO 197 Belvoir Road Williamsville, NY 14221

Re: K992836 Trade Name: Slit Lamp Regulatory Class: II Product Code: 86 HJO Dated: October 6, 1999 Received: October 13, 1999

Dear Mr. Miner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. R. Brent Miner

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl. Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (If known): K992836

Device Name: Biomicroscope, Slit Lamp AC Powered

Indication for Use: SL 990, SL 980, SL 950

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An AC-powered slitlamp biomicroscope is intended . for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment

Daryl Kaufman
(Division Sign-Off)

Division Sign-Off) Division of Ophthalmic Devices 992836 ( 510(k) Number _

(PLEASE DO NOT WRITE BETOM THIS LINE-CONTINUE ON ANOTHE IF NEEDED I

Concurrence of corth, Office of Device Evaluation (

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter<br>(Optional Format)<br>FDA/CDRH/ODE/DMC<br>13 DEC 93 08 32 |
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