Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5900](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5900) → HPG — Aid, Vision, Electronic, Battery-Powered

# HPG · Aid, Vision, Electronic, Battery-Powered

_Ophthalmic · 21 CFR 886.5900 · Class 1_

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

## Overview

- **Product Code:** HPG
- **Device Name:** Aid, Vision, Electronic, Battery-Powered
- **Regulation:** [21 CFR 886.5900](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5900)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K910601](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K910601.md) | PATHFINDER | Nurion Industries | May 14, 1991 | SESE |
| [K910124](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K910124.md) | LOW VISION ENHANCEMENT SYSTEM (LVES) | Triangle Investments | Apr 10, 1991 | SESE |
| [K903558](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K903558.md) | LASER CANE | Nurion Industries | Sep 27, 1990 | SESE |
| [K902187](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K902187.md) | POLARON | Nurion Industries | Aug 8, 1990 | SESE |
| [K862338](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K862338.md) | SENSORY 6 | Brytech, Inc. | Sep 3, 1986 | SESE |
| [K823385](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K823385.md) | ALES | Oms | Mar 9, 1983 | SESE |
| [K761215](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPG/K761215.md) | F4912 NIGHT VISION AID | Itt Corp. | Dec 16, 1976 | SESE |

## Top Applicants

- Nurion Industries — 3 clearances
- Brytech, Inc. — 1 clearance
- Itt Corp. — 1 clearance
- Oms — 1 clearance
- Triangle Investments — 1 clearance

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

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