BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Femtosecond Laser System For Refractive Correction

    PMA: P150040 · Supplement: S024 · Decision May 26, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Femtosecond Laser System For Refractive Correction
    Trade Name
    VISUMAX 800 Femtosecond Laser
    PMA Number
    P150040
    Supplement Number
    S024
    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
    May 26, 2026
    Date Received
    February 23, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    design changes to the laser sources to address temperature-induced laser beam drift

    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