← Product Code [HPG](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG) · K862338

# SENSORY 6 (K862338)

_Brytech, Inc. · HPG · Sep 3, 1986 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K862338

## Device Facts

- **Applicant:** Brytech, Inc.
- **Product Code:** [HPG](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG.md)
- **Decision Date:** Sep 3, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5900
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K862338](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K862338)

**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
