BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930034 · Supplement: S009 · Decision Mar 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS DISC
    PMA Number
    P930034
    Supplement Number
    S009
    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 11, 1998
    Date Received
    April 2, 1997
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    98M-0329

    Advisory Committee Statement

    Approval for the SVS Apex Plus Excimer Laser Workstation and emphasis(R) disc. These devices are indicated to perform myopic astigmatic photorefractive keratectomy (Toric PRK): 1) for the reduction or elimination of mild to moderate myopia (-1.00 to < -6.00 D) and concomitant reduction or elimination of mild to moderate astigmatism (-1.00 to < -4.00D), in which the combined attempted correction must be < -6.00D spherical equivalent at the spectacle plane; 2) in patients with documentation of a stable manifest refraction(+- 1D) over the past year; and, 3) in patients who are 21 years of age or older.

    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