BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Photodynamic Therapy

    PMA: P990021 · Supplement: S005 · Decision Mar 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Laser, Photodynamic Therapy
    Trade Name
    PHOTOFRIN 630 PDT Laser
    PMA Number
    P990021
    Supplement Number
    S005
    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
    March 2, 2022
    Date Received
    April 27, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for PHOTOFRIN® 630 PDT Laser, Model BWF5-630-2-PI (an updated design of the currently marketed laser, the DIOMED 630 PDT Laser, Model T2USA), and B&W TEK Inc., located at 18 Shea Way, Suite 103, Newark, DE, 19713 as the new manufacturing site of the PHOTOFRIN® 630 PDT Laser, Model BWF5-630-2-PIN.

    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