BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P020050 · Supplement: S023 · Decision Nov 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
    PMA Number
    P020050
    Supplement Number
    S023
    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 21, 2016
    Date Received
    July 20, 2015
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    16M-4046

    Advisory Committee Statement

    Approval for the WaveLight EX500 Excimer Laser System and Allegretto Wave Eye-Q Excimer Laser System. These devices are indicated for use in Photorefractive Keratectomy (PRK) treatments for: 1) the reduction or elimination of up to -6.0 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -6.0 D of spherical component and up to -3.0 D of astigmatic component at the spectacle plane;2) patients who are 18 years of age or older; and 3) patients with documentation of a stable manifest refraction defined as <=0.5 D preoperative spherical equivalent shift over one year prior to surgery.

    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