← Product Code [HKN](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKN) · K936205

# COMPREHENSIVE PHOROPTER, MDR-680 (K936205)

_Canon USA, Inc. · HKN · Sep 28, 1994 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKN/K936205

## Device Facts

- **Applicant:** Canon USA, Inc.
- **Product Code:** [HKN](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKN.md)
- **Decision Date:** Sep 28, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1770
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKN/K936205](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKN/K936205)

**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