Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5915](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5915) → HPI — Aid, Vision, Optical, Ac-Powered

# HPI · Aid, Vision, Optical, Ac-Powered

_Ophthalmic · 21 CFR 886.5915 · Class 1_

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

## Overview

- **Product Code:** HPI
- **Device Name:** Aid, Vision, Optical, Ac-Powered
- **Regulation:** [21 CFR 886.5915](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5915)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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.

## Classification Rationale

Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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