Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1070](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1070) → HIW — Anomaloscope

# HIW · Anomaloscope

_Ophthalmic · 21 CFR 886.1070 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIW

## Overview

- **Product Code:** HIW
- **Device Name:** Anomaloscope
- **Regulation:** [21 CFR 886.1070](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1070)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An anomaloscope is an AC-powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be matched by the patient.

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K930575](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIW/K930575.md) | KAMPPETER ANOMALOSCOPE | Bova Intl. | Feb 25, 1994 | SESE |
| [K913962](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIW/K913962.md) | ANOMALOSCOPE QUADRANT TEST-6 | Lkc Technologies, Inc. | Oct 23, 1991 | SESE |
| [K860174](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIW/K860174.md) | GUNKEL CHROMAGRAPH COLOR VISION TESTER | Chromagraphics, Inc. | Apr 4, 1986 | SESE |

## Top Applicants

- Bova Intl. — 1 clearance
- Chromagraphics, Inc. — 1 clearance
- Lkc Technologies, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIW](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIW)

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