← Product Code [HQY](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY) · K971249

# GOLDEN STATE IMPORTS INTERNATIONAL, INC./ COLEMAN (K971249)

_Andrew G. Halpern · HQY · May 6, 1997 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K971249

## Device Facts

- **Applicant:** Andrew G. Halpern
- **Product Code:** [HQY](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY.md)
- **Decision Date:** May 6, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5850
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K971249](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQY/K971249)

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