← Product Code [HOI](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI) · K910329

# SUNGLASSES (K910329)

_Cutler & Gross Sloan Optical , Ltd. · HOI · Mar 12, 1991 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K910329

## Device Facts

- **Applicant:** Cutler & Gross Sloan Optical , Ltd.
- **Product Code:** [HOI](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI.md)
- **Decision Date:** Mar 12, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5840
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K910329](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K910329)

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