← Product Code [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) · K001176

# DISPOSABLE MICROKERATOME BLADES-PE (K001176)

_Oasis Medical, Inc. · HNO · Sep 21, 2000 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K001176

## Device Facts

- **Applicant:** Oasis Medical, Inc.
- **Product Code:** [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO.md)
- **Decision Date:** Sep 21, 2000
- **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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K001176](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K001176)

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