BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Optical Diagnostic Device For Melanoma Detection

    PMA: P090012 · Supplement: S007 · Decision Nov 26, 2014
    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
    S007
    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
    November 26, 2014
    Date Received
    April 29, 2014
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CHANGES LISTED BELOW:1) INITIAL RELEASE OF USB 2.0 FOR HAND-HELD IMAGER; 2) REDESIGNED CARD READER ASSEMBLY; 3) RELEASED ACCESSORY KIT WITH DIGITAL CAMERA; 4) HIGH CAPACITY CARD OPTION ADDED; AND 5) MODIFIED PHANTOM FIXTURE MECHANICAL TOLERANCES.

    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