BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Femtosecond Laser System For Refractive Correction

    PMA: P150040 · Supplement: S020 · Decision Dec 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Femtosecond Laser System For Refractive Correction
    Trade Name
    VisuMax; VISUMAX 800
    PMA Number
    P150040
    Supplement Number
    S020
    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
    December 18, 2025
    Date Received
    June 23, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    labeling update that includes the Post-Approval study data from the VisuMax SMILE New Enrollment Study for the VisuMax Femtosecond Laser

    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