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510(k) Data Aggregation

    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
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MED-LOGICS, MODEL ML7090

    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.

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