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) → MYD — Keratome, Water Jet

# MYD · Keratome, Water Jet

_Ophthalmic · 21 CFR 886.4370 · Class 1_

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

## Overview

- **Product Code:** MYD
- **Device Name:** Keratome, Water Jet
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K991124](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MYD/K991124.md) | VISIJET HYDROKERATOME, MODEL 50 | Visijet, Inc. | Oct 20, 2000 | SESE |

## Top Applicants

- Visijet, Inc. — 1 clearance

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

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