← Product Code [HJF](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJF) · K820375

# PLASTIC OR GLASS MAGNIFIER (K820375)

_Gazelle Corp. · HJF · Jun 14, 1982 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJF/K820375

## Device Facts

- **Applicant:** Gazelle Corp.
- **Product Code:** [HJF](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJF.md)
- **Decision Date:** Jun 14, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5540
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJF/K820375](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJF/K820375)

**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