BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Optical Diagnostic Device For Melanoma Detection

    PMA: P090012 · Supplement: S011 · Decision Aug 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Optical Diagnostic Device For Melanoma Detection
    Trade Name
    MELAFIND
    PMA Number
    P090012
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    OYD
    Generic Name
    Optical diagnostic device for melanoma detection
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 18, 2016
    Date Received
    June 11, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changing your calibration validation self-test method from the Field Phantom Imaging Self-Test to the Flap Shutter Self-Test.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OYD Optical Diagnostic Device For Melanoma Detection