D'ARC EYE CARE SUNGLASSES

K972490 · M & R Dist. · HQY · Jul 25, 1997 · Ophthalmic

Device Facts

• Record ID: K972490
• Device Name: D'ARC EYE CARE SUNGLASSES
• Applicant: M & R Dist.
• Product Code: HQY · Ophthalmic
• Decision Date: Jul 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5850
• Device Class: Class 1

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.

Device Story

D'Arc Eye Care System Sunglasses consist of spectacle frames or clips featuring absorbing, reflective, tinted, polarizing, or photosensitized lenses. Device functions as passive optical filter to attenuate bright sunlight exposure. Intended for over-the-counter use by general population to protect eyes from solar radiation. No refractive correction provided. Clinical benefit derived from reduction of ocular glare and UV/visible light intensity.

Clinical Evidence

No clinical data provided; device is a standard nonprescription sunglass product.

Technological Characteristics

Spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses. Class I medical device.

Indications for Use

Indicated for individuals requiring eye protection from bright sunlight. Nonprescription device; not for refractive correction. Available over-the-counter.

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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JUL 25 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Max Sher M & R Distributors 1219 Sunset Plaza Drive #4 Los Angeles, CA 90069

· Re: K972490 Trade Name: D'Arc Eye Care System Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: June 28, 1997 Received: July 2, 1997

Dear Mr. Sher:

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. Max Sher

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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K972490 510(k) Number (if known):

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.

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Concurrence of CDRH, Office of Device Evaluation (ODF)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K972490

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use XXX

(Optional Format 1-2-96)