KEELER TEARSCOPE-PLUS

K973064 · Keeler Instruments, Inc. · HJO · Apr 7, 1998 · Ophthalmic

Device Facts

• Record ID: K973064
• Device Name: KEELER TEARSCOPE-PLUS
• Applicant: Keeler Instruments, Inc.
• Product Code: HJO · Ophthalmic
• Decision Date: Apr 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

Specular Observation of the tear film

Device Story

Keeler Tearscope-Plus is an ophthalmic diagnostic device used for the specular observation of the tear film. It allows clinicians to visualize and assess the tear film layer, aiding in the evaluation of ocular surface health. The device is intended for use by eye care professionals in a clinical setting. By providing a magnified view of the tear film, it assists the physician in diagnosing conditions related to tear film stability and quality, facilitating informed clinical decision-making regarding patient ocular care.

Clinical Evidence

No clinical data provided; device cleared via 510(k) based on substantial equivalence to existing ophthalmic diagnostic instrumentation.

Technological Characteristics

Ophthalmic diagnostic device for tear film observation. Class II device (Product Code 86 HJO). Operates as a specialized viewing instrument for clinical examination.

Indications for Use

Indicated for specular observation of the tear film in patients requiring ophthalmic examination.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 1998

Mr. Eugene R. Van Arsdale Marketing Manager Keeler Instruments, Inc. 456 Parkway Broomall, PA 19008

Re: K973064

> Trade Name: KEELER TEARSCOPE-PLUS Regulatory Class: II Product Code: 86 HJO Dated: February 11, 1998 Received: February 17, 1998

Dear Mr. Arsdale:

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. Eugene R. Van Arsdale

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. Ralph 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): K973064

Device Name: Keeler Tearscope-Plus

Indications For Use: Specular Observation of the tear film

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use - تا

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Over-The-Counter USE__________________________________________________________________________________________________________________________________________________________

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hthalmic 510(k) Number

(Optional Format 1-2-96)