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510(k) Data Aggregation

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

    ML MICROKERATOME

    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.

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    K Number
    K962661
    Device Name
    ML MICROKERATOME BLADE
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    1996-12-09

    (154 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ML MICROKERATOME BLADE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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