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K Number
K981071
Device Name
ML MICROKERATOME
Manufacturer
MED-LOGICS, INC.
Date Cleared
1998-07-23

(121 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 ML Microkeratome is used to perform lamellar keratoplasty procedures. This procedure is no I he ML MICrokeratome is used to perform athin circular corneal cap.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the ML Microkeratome, acknowledging its substantial equivalence to a predicate device. It does not include details about device performance, specific acceptance criteria, study methodologies, or training data for AI models.

§ 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.