BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P990048 · Supplement: S003 · Decision Oct 31, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER
    PMA Number
    P990048
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MVF
    Generic Name
    SYSTEM, LASER, PHOTODYNAMIC THERAPY
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 31, 2008
    Date Received
    April 22, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE LASER CONTROLLER; THE ADDITION OF NEW USER INTERFACE INCLUDING TOUCH-SENSITIEVE SCREEN AND ROTARY KNOBS; A NEW INTEGRATED POWER SUPPLY WITH MICRO-CONTROLLER ELECTRONIC COMPONENTS; NEW LABELING; AND NEW SOFTWARE (FIRMWARE). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULAS 690PLUS AND VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE IN VISUDYNE THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE (VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO MACULAR DEGENERATION, PRESUMED OCULAR HISTOPLASMOSIS OR PATHOLOGIC MYOPIA.

    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