BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Femtosecond Laser System For Refractive Correction

    PMA: P150040 · Supplement: S003 · Decision Oct 4, 2018
    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
    S003
    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 4, 2018
    Date Received
    March 23, 2018
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    18M-3842

    Advisory Committee Statement

    Approval for the VisuMax Femtosecond Laser. This device is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism:1) For spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters;2) For cylinder from -0.75 diopters through -3.00 diopters; and3) When refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D in magnitude.

    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