BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Femtosecond Laser System For Refractive Correction

    PMA: P150040 · Supplement: S018 · Decision Oct 16, 2024
    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
    PMA Number
    P150040
    Supplement Number
    S018
    Device Class
    FDA Class 3
    Product Code
    OTL
    Generic Name
    Femtosecond laser system for refractive correction
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 16, 2024
    Date Received
    July 24, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    the replacement of the last two lead-containing lenses (F2 glass material) in the Scanoptics Complete Module of the VisuMax Femtosecond Laser with optional lead-free lenses (N-F2 glass material).

    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