SUNGLASSES

K971385 · Kosway Industries Co., Ltd. · HQY · Jul 14, 1997 · Ophthalmic

Device Facts

• Record ID: K971385
• Device Name: SUNGLASSES
• Applicant: Kosway Industries Co., Ltd.
• Product Code: HQY · Ophthalmic
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5850
• Device Class: Class 1

Intended Use

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.

Device Story

Nonprescription sunglasses consisting of frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses. Used by general population to protect eyes from bright sunlight. Available over-the-counter. Device functions as passive optical filter to reduce light intensity reaching eyes.

Technological Characteristics

Spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses. Passive optical device.

Indications for Use

Indicated for individuals requiring eye protection from bright sunlight. Nonprescription use; not for refractive correction.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 1997

Mr. Henry Ko . ...... . Kosway Industries Co., Ltd. Flat 12, 12/F, Block B Goodview Industrial Bldg. 11 Kin Fat St., Tuen Mun, N.T. Hong Kong

Re: K971385 -- --Trade Name: Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: June 20, 1997 Received: June 30, 1997

Dear Mr. Ko:

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 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. Henry Ko

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): K971385

Device Name: Sunglasses

Indications For Use:

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.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEDI

Concurrence of CDRH, Office of Device Evaluation (CDE)

AmWilliame

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971385

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use XXX

(Optional Format 1-2-96)