BEUDAMED
    FDA PMA Approved (Withdrawn) 🇺🇸 United States

    PMA: P970049 · Decision Dec 16, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    DISHLER EXCIMER LASER SYSTEMS
    PMA Number
    P970049
    Advisory Committee
    Neurology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 16, 1999
    Date Received
    October 6, 1997
    Expedited Review
    N
    Docket Number
    01M-0043

    Advisory Committee Statement

    Approval for LASIK in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from -0.5 to -13.0 diopters (D) MRSE (manifest refraction spherical equivalence) with or without -0.5 D to - 4.0 D astigmatism; and in patients with documented evidence of changes refraction of less than or equal to 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of preoperative examination.