CEBE

K971644 · Suunto USA · HQY · Jun 24, 1997 · Ophthalmic

Device Facts

• Record ID: K971644
• Device Name: CEBE
• Applicant: Suunto USA
• Product Code: HQY · Ophthalmic
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5850
• Device Class: Class 1

Intended Use

Eye Protection against ultra violet radiation.

Device Story

CEBE Sunglasses provide eye protection against ultraviolet radiation. Device is intended for over-the-counter use by the general public. Sunglasses function as a physical barrier to block UV light transmission to the eyes. No complex electronics, software, or automated processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-electronic, passive optical device. Materials and construction typical of standard sunglasses for UV filtration.

Indications for Use

Indicated for eye protection against ultraviolet radiation for the general population.

Regulatory Classification

Identification

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol, indicating the organization's name and national affiliation. The overall design is simple and conveys a sense of authority and public service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 24 1997

Mr. Henri Syvanėn Suunto USA 2151 Las Palmas Drive Suite G Carlsbad, CA 92009

Re: K971644 Trade Name: CEBE Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: April 22, 1997 Received: May 5, 1997

Dear Mr. Syvanen:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Henri Syvanen

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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Page

510(k) Number (if known): K971644

Device Name:__CEBE SUNGLASSES

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Eye Protection against ultra violet Indications For Use: radiation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Am Williams
Sign-Off
of Ophthalmic Devices
Number K971644

Preseription Use (Per 21 CFR 801 109) ામ

Gver-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Formal 1-2-96)