Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4370](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4370) → HMY — Keratome, Battery-Powered

# HMY · Keratome, Battery-Powered

_Ophthalmic · 21 CFR 886.4370 · Class 1_

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

## Overview

- **Product Code:** HMY
- **Device Name:** Keratome, Battery-Powered
- **Regulation:** [21 CFR 886.4370](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4370)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class I.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K040297](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K040297.md) | ONEUSE- PLUS MICROKERATOME | Moria SA | Mar 31, 2004 | SESE |
| [K023092](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K023092.md) | BD K-4000 MICROKERATOME SYSTEM | Becton, Dickinson & CO | Oct 18, 2002 | SESE |
| [K022637](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K022637.md) | BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME | Becton, Dickinson & CO | Oct 16, 2002 | SESE |
| [K022560](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K022560.md) | M2 SINGLE USE MICROKERTOME | Moria SA | Sep 27, 2002 | SESE |
| [K003594](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K003594.md) | CARRIAZO BARRAQUER SINGLE USE MICROKERATOME | Moria, Inc. | Mar 9, 2001 | SESE |
| [K002191](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K002191.md) | CARRIAZO BARRAQUER II MICROKERATOME | Moria, Inc. | Oct 12, 2000 | SESE |
| [K992687](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K992687.md) | MILLENIUM MICROKERATOME, MODEL IMD-001 | Industrial & Medical Design, Inc. | Sep 24, 1999 | SESE |
| [K984537](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K984537.md) | KERATOME SYSTEM, MODEL K3000 | Insight Technologies Instruments, LLC | May 14, 1999 | SESE |
| [K981741](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K981741.md) | CARRIAZO BARRAQUER MICROKERATOME | Moria, Inc. | Jul 24, 1998 | SESE |
| [K974243](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K974243.md) | KERATOME SYSTEM | Insight Technologies Instruments, LLC | Jan 20, 1998 | SESE |
| [K902857](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K902857.md) | VISI-DRAPE OPHTHALMIC DRAPES | Visitec Co. | Jul 31, 1990 | SESE |
| [K781412](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K781412.md) | OSCILLATING KNIFE AND ACCESSORIES | Codman & Shurtleff, Inc. | Oct 11, 1978 | SESE |

## Top Applicants

- Moria, Inc. — 3 clearances
- Becton, Dickinson & CO — 2 clearances
- Insight Technologies Instruments, LLC — 2 clearances
- Moria SA — 2 clearances
- Codman & Shurtleff, Inc. — 1 clearance

---

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

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