← Product Code [HJG](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG) · K915340

# MENTOR HORIZON LOW VISION MAGNIFIER (K915340)

_Mentor O & O, Inc. · HJG · Mar 30, 1992 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K915340

## Device Facts

- **Applicant:** Mentor O & O, Inc.
- **Product Code:** [HJG](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG.md)
- **Decision Date:** Mar 30, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5820
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K915340](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K915340)

**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
