DUQIAO

K971551 · Duqiao Glasses (Group) Co. , Ltd. · HQY · Jun 4, 1997 · Ophthalmic

Device Facts

• Record ID: K971551
• Device Name: DUQIAO
• Applicant: Duqiao Glasses (Group) Co. , Ltd.
• Product Code: HQY · Ophthalmic
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5850
• Device Class: Class 1

Intended Use

The sunglasses we produce consist of metal or plastic frames with absorbing, reflective, tinted or photosensitized "Impact Resistant Lenses" made from glass or plastic. As a medical device, its main use is to protect the eyes from bright sunlight. It is available in touring, sport and other model types but should not be used in situations requiring industrial safety lenses. It also can't provide refractive corrections.

Device Story

Sunglasses consist of metal or plastic frames with impact-resistant glass or plastic lenses. Lenses are absorbing, reflective, tinted, or photosensitized. Device is used by general public to protect eyes from bright sunlight. Available in various styles (touring, sport). Not intended for industrial safety or refractive correction. No electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metal or plastic frames; impact-resistant glass or plastic lenses; absorbing, reflective, tinted, or photosensitized coatings. No energy source, connectivity, or software.

Indications for Use

Indicated for protection of eyes from bright sunlight for general population. Not for use in industrial safety applications. 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

JUN - 4 1997

Ms. Merry Chen Dugiao Glasses (Group) Co., Ltd. 279 Fugian Street, Duqiao Linhai, Zhejiang China

Re: K971551 -Trade Name: Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: April 1, 1997 Received: April 28, 1997

Dear Ms. Chen:

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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 - Ms. Merry Chen

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 L. 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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## INDICATION FOR USE STATEMENT

510(K) Number: K971551

## Device Name: Sunglasses -

Indication For Use:

The sunglasses we produce consist of metal or plastic frames with absorbing, reflective, tinted or photosensitized "Impact Resistant Lenses" made from glass or plastic.

As a medical device, its main use is to protect the eyes from bright sunlight. It is available in touring, sport and other model types but should not be used in situations requiring industrial safety lenses. It also can't provide refractive corrections.

Am William
(Division Sign-Off)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K97155T

Over-the-Counter Use