BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P990048 · Decision Apr 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER
    PMA Number
    P990048
    Device Class
    FDA Class 3
    Product Code
    MVF
    Generic Name
    SYSTEM, LASER, PHOTODYNAMIC THERAPY
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 12, 2000
    Date Received
    August 16, 1999
    Expedited Review
    N
    Docket Number
    00M-1300

    Advisory Committee Statement

    Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.

    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