BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Fiber Optic, Photodynamic Therapy

    PMA: P940010 · Supplement: S016 · Decision May 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Laser, Fiber Optic, Photodynamic Therapy
    Trade Name
    OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series)
    PMA Number
    P940010
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    MVG
    Generic Name
    SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 9, 2019
    Date Received
    December 19, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the design update for the OPTIGUIDE Diffusing Fiber Optics for the new series identified as the PB200 and PB700 Series of OPTIGUIDE Diffusing Fiber Optics and for the approval of a new manufacturing site. The new manufacturing site is Laser Peripherals LLC, 13355 10th Avenue, North Suite #110, Plymouth, Minnesota.

    Classifications

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

    Product Code Device Name
    MVG System, Laser, Fiber Optic, Photodynamic Therapy