BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970043 · Supplement: S004 · Decision Sep 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    LADAR VISION TREATMENTS
    PMA Number
    P970043
    Supplement Number
    S004
    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
    September 24, 1999
    Date Received
    August 19, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding software computer screens to provide precautions when refractive parameters were entered that were outside the approved indications for use. These indications for use remain: PRK for the reduction or elimination of -1.00 to -10.00 D of spherical myopia with or without -1.00 to -4.00 D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50 and -10.00 D SE at the spectacle plane where sphere or cylinder magnitude is at least 1.00 D.

    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