BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Fiber Optic, Photodynamic Therapy

    PMA: P940010 · Supplement: S012 · Decision Jan 17, 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 Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series)
    PMA Number
    P940010
    Supplement Number
    S012
    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
    January 17, 2018
    Date Received
    October 24, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for replacement resin for the manufacturing of "heat shrink" tubing used in all sizes of the DCYL 200 Series fibers (DCYL 210, 215,220,225, 250).

    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