BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930016 · Supplement: S006 · Decision Mar 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    VISX STAR S2 EXCIMER LASER SYSTEM
    PMA Number
    P930016
    Supplement Number
    S006
    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
    March 20, 1998
    Date Received
    February 26, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for for 1)laser removal of the epithelium; 2)visibility upgrade; 3)swivel mounted vacuum nozzle; 4)integrated hardware module with all unapproved indications "locked out"; 5)variable Hertz rate from 1.5 to 10 Hertz; 6)smoothing; 7)installation of software Version 2.2 with all unapproved indications "locked out"; and, 8)revised Operator's Manual. The device as modified will be marketed under the trade name VISX START S2 Excimer Laser System and is indicated for myopic and astigmatic PRK using an ablation zone with a 6.0mm major axis. The PRK procedure is intended for use: 1)in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2)in patient 18-20 years of age in PRK treatment for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0D sphereical equivalent at the corneal plane with less than or equal to -1.0D of astigmatism; or 3)in patients 21 years of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0D spherical myopia at the spectacle plane and up to -4.0D of astigmatism.

    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