BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Laser, Fiber Optic, Photodynamic Therapy

    PMA: P940010 · Supplement: S013 · Decision Jan 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Laser, Fiber Optic, Photodynamic Therapy
    Trade Name
    Optiguide Cylindrical Fiber Optic
    PMA Number
    P940010
    Supplement Number
    S013
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 13, 2018
    Date Received
    December 18, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of a manual heating method to be added as an alternative method for the formation of the rounded tip of the cap sub-assembly using ETFE tubing.

    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