BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Fiber Optic, Photodynamic Therapy

    PMA: P940010 · Decision Dec 27, 1995
    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
    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
    December 27, 1995
    Date Received
    April 13, 1994
    Expedited Review
    N
    Docket Number
    97M-0204

    Advisory Committee Statement

    APPROVAL FOR OPTIGUIDE FIBER OPTIC DIFFUSER, MODELS DCYL 10, DCYL 15, DCYL 25

    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