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K Number
K033293
Device Name
MED-LOGICS, MODEL ML7090
Manufacturer
MED-LOGICS, INC.
Date Cleared
2004-01-13

(91 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 MED-LOGICS ML7090 microkeratome blades are to be used, as replacement blades for the AMO Amadeus TM Microkeratome, to perform lamellar keratectomy procedures.

Device Description

Microkeratome Blade

AI/ML Overview

This document is a 510(k) premarket notification acceptance letter from the FDA for the ML 7090 Microkeratome Blade. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Since the device is a Class 1 device, it is exempt from needing clinical studies, hence, the document does not mention any such studies.

§ 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.