BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P990048 · Supplement: S002 · Decision Jul 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    VISULAS 690S LASER AND VISULINK PDT ADAPTER
    PMA Number
    P990048
    Supplement Number
    S002
    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
    July 3, 2001
    Date Received
    March 9, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE VISULINK PDT ADAPTER IN ORDER TO MAKE THE VISULAS 790S LASER COMPATIBLE WITH BOTH ZEISS AND HAAG STREIT SLIT LAMPS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE WITH THE VISULAS 690S LASER THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE(VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION (AMD) IN PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION( CNV).

    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