← Product Code [HPE](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPE) · K884540

# ETV, ELECTRONIC VISION AID (K884540)

_Sevrain-Tech, Inc. · HPE · Jan 19, 1989 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPE/K884540

## Device Facts

- **Applicant:** Sevrain-Tech, Inc.
- **Product Code:** [HPE](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPE.md)
- **Decision Date:** Jan 19, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5915
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPE/K884540](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HPE/K884540)

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