← Product Code [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) · K903912

# KERATOME (K903912)

_Micro Precision Instrument Co. · HNO · Oct 17, 1990 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K903912

## Device Facts

- **Applicant:** Micro Precision Instrument Co.
- **Product Code:** [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO.md)
- **Decision Date:** Oct 17, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4370
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K903912](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K903912)

**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
