Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5910](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5910) → HOT — Aid, Vision Image Intensification

# HOT · Aid, Vision Image Intensification

_Ophthalmic · 21 CFR 886.5910 · Class 1_

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

## Overview

- **Product Code:** HOT
- **Device Name:** Aid, Vision Image Intensification
- **Regulation:** [21 CFR 886.5910](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5910)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **GMP exempt:** yes

## Identification

An image intensification vision aid is a battery-powered device intended for use by a patient who has limited dark adaptation or impaired vision to amplify ambient light.

## 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. The 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K873967](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOT/K873967.md) | SPECTACLE, MAGNIFYING | Swank Plus , Ltd. | Feb 26, 1988 | SESE |
| [K863994](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOT/K863994.md) | VIEWSCAN | Sensory Aids Corp. | Oct 31, 1986 | SESE |

## Top Applicants

- Sensory Aids Corp. — 1 clearance
- Swank Plus , Ltd. — 1 clearance

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

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