← Product Code [HIT](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT) · K844365

# COLOR VISION TESTERS (K844365)

_Luneau Laboratories · HIT · Jan 2, 1985 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT/K844365

## Device Facts

- **Applicant:** Luneau Laboratories
- **Product Code:** [HIT](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT.md)
- **Decision Date:** Jan 2, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1170
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT/K844365](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT/K844365)

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