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K Number
K974598
Device Name
MICROKERATOME OR THE MATE
Manufacturer
HOWARD INSTRUMENTS, INC.
Date Cleared
1998-04-22

(134 days)

Product Code
HNO
Regulation Number
886.4370
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MMK-1000 is designed to produce a corneal flap.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a microkeratome device. It does not contain information about acceptance criteria, device performance, or any studies using AI. The letter is a regulatory approval document confirming the device's substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given input.

§ 886.4370 Keratome.

(a)
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.(b)
Classification. Class I.