BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970043 · Supplement: S007 · Decision Sep 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    LADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
    PMA Number
    P970043
    Supplement Number
    S007
    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 22, 2000
    Date Received
    September 3, 1999
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    Y
    Docket Number
    00M-1612

    Advisory Committee Statement

    APPROVAL FOR THE LADARVISION(R) EXCIMER LASER SYSTEM. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATINO OF REFRACTIVE ERROR OF LESS THAN OR EQUAL TO +6.00D OF SPHERE AND -6.00D OF CYLINDER AT THE SPECTACLE PLANE (HYPEROPIA WITH OR WITHOUT ASTIGMATISM AND MIXED ASTIGMATISM); 1) IN SUBJECTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50D FOR CORRECTIONS UP TO +6.00D SE; AND, 3) IN SUBJECTS 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