PATHFINDER SUNGLASSES

K971495 · Coil · HQY · May 29, 1997 · Ophthalmic

Device Facts

• Record ID: K971495
• Device Name: PATHFINDER SUNGLASSES
• Applicant: Coil
• Product Code: HQY · Ophthalmic
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5850
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

COIL Pathfinder Sunglasses are intended to be worn by a person to protect the eyes from bright sunlight, but do not provide for refractive correction.

Device Story

Pathfinder Sunglasses are nonprescription eyewear designed to protect eyes from bright sunlight. Device is intended for use by adults and children. Operated by user; worn as standard sunglasses. Provides ocular protection from solar radiation; does not offer refractive correction.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nonprescription sunglasses; Class I device (21 CFR 886.5850). No refractive correction provided.

Indications for Use

Indicated for adults and children to protect eyes from bright sunlight. Does not provide 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

MAY 2 9 1997

Ms. Janice Popielewski COIL, A Division of COIN Controls, Inc. c/o Medical Reports Exchange, Inc. 1314 North Hunter St. Suite 202 Baltimore, MD 21202

Re: K971495 Trade Name: Pathfinder Sunglasses Regulatory Class: I Product Code: 86 HQY Dated: April 22, 1997 Received: April 24, 1997

Dear Ms. Popielewski:

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. Janice Popielewski

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 at [phone].

Sincerely yours,
Alberl 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):

Device Name: Sunglasses, Nonprescription, Class I 886.5850, 86HQY

Indications for Use: ---------------------------------------------------------------------------------------------------------------------------------------------------------

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COIL Pathfinder Sunglasses are intended to be worn by a person to protect the eyes from bright sunlight, but do not provide for refractive correction.

Target Population: Adult and Child

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*An Williams*

*Division of Ophthalmic Devices*

| Prescription Use | OR | <div style="border: 1px solid black; border-radius: 50%; width: 100px; height: 50px; position: relative; left: 50px; top: 0px;">Over-the-Counter</div> |
|----------------------|----|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Use | | |
| (Per 21 CFR 801.109) | | |