BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P990010 · Decision Nov 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    VISX EXCIMER LASER SYSTEM MODEL C STAR
    PMA Number
    P990010
    Device Class
    FDA Class 3
    Product Code
    LZS
    Generic Name
    Excimer laser system
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 19, 1999
    Date Received
    February 23, 1999
    Expedited Review
    N
    Docket Number
    00M-1447

    Advisory Committee Statement

    Approval for the VISX Excimer Laser System Model C (STAR S2) which included the right to reference information contained in P930016 from VISX, Inc., of Santa Clara, CA. This device is indicated to perfrom LASIK: 1) in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from 0 to -14.0 diopters (D) with or without -0.5 D to -5.0 D of astigmatism; and 2) in patients with documented evidence of a change in manifest refraction of less than or equalto 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of pre-operative examination.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZS Excimer Laser System