BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Laser, Fiber Optic, Photodynamic Therapy

    PMA: P940010 · Supplement: S017 · Decision Feb 24, 2021
    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
    S017
    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
    February 24, 2021
    Date Received
    November 2, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of the PB900 series to OPTIGUIDE® Cylindrical Diffuser fiber optics. The change being made (due to addition of the fiber that is equivalent to PB200 and PB700 fibers) is in two quality control procedures to accommodate the smaller diameter of this design.

    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