BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Fiber Optic, Photodynamic Therapy

    PMA: P940010 · Supplement: S001 · Decision Aug 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Laser, Fiber Optic, Photodynamic Therapy
    Trade Name
    OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
    PMA Number
    P940010
    Supplement Number
    S001
    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
    August 7, 1996
    Date Received
    July 3, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGE IN LABELING CONSISTING OF ADDING AN ADDITIONAL WARNING STATEMENT CONCERNING POSSIBLE LEAKAGE OF BLOOD INTO DIFFUSER CAP

    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