BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P990019 · Supplement: S004 · Decision Sep 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
    PMA Number
    P990019
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MVF
    Generic Name
    SYSTEM, LASER, PHOTODYNAMIC THERAPY
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 21, 2006
    Date Received
    August 22, 2006
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    USE OF AN ALTERNATE MANUFACTURER FOR THE TIMER ASSEMBLY IN THE DEVICE.

    Classifications

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

    Product Code Device Name
    MVF System, Laser, Photodynamic Therapy