← Product Code [HQY](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY) · K971495 # PATHFINDER SUNGLASSES (K971495) _Coil · HQY · May 29, 1997 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K971495 ## Device Facts - **Applicant:** Coil - **Product Code:** [HQY](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY.md) - **Decision Date:** May 29, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.5850 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic - **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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread. 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. {1}------------------------------------------------ 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597. 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 {2}------------------------------------------------ 510(k) Number (if known): Device Name: Sunglasses, Nonprescription, Class I 886.5850, 86HQY Indications for Use: --------------------------------------------------------------------------------------------------------------------------------------------------------- . The The The State of the States of the States of the States of the States of the States of the States of the States of the States of the States of the States of the Childre 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 ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) *An Williams* *Division of Ophthalmic Devices* | Prescription Use | OR |
Over-the-Counter
| |----------------------|----|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Use | | | | (Per 21 CFR 801.109) | | | --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K971495](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K971495) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com