← Product Code [HIT](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT) · K831074

# OSCAR COLOR VISION TESTER (K831074)

_Carl Zeiss, Inc. · HIT · Apr 28, 1983 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT/K831074

## Device Facts

- **Applicant:** Carl Zeiss, Inc.
- **Product Code:** [HIT](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT.md)
- **Decision Date:** Apr 28, 1983
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT/K831074](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT/K831074)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com