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

    Femtosecond Laser System For Refractive Correction

    PMA: P150040 · Supplement: S014 · Decision Aug 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Femtosecond Laser System For Refractive Correction
    Trade Name
    VisuMax Femtosecond Laser Accessory– Treatment Pack
    PMA Number
    P150040
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    OTL
    Generic Name
    Femtosecond laser system for refractive correction
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 15, 2023
    Date Received
    July 17, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Second clean room for the manufacture of the Treatment Pack Accessory at the Jena, Germany manufacturing site.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OTL Femtosecond Laser System For Refractive Correction