BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970043 · Supplement: S010 · Decision Oct 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    LADARVISION 4000 EXCIMER LASER SYSTEM
    PMA Number
    P970043
    Supplement Number
    S010
    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
    October 18, 2002
    Date Received
    March 18, 2002
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    02M-0487

    Advisory Committee Statement

    APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM. THIS DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, IS LOCKED-OUT FOR TREATMENTS ABOVE -7.0 DIOPTERS (D) AS MEASURED BY MANIFEST REFRACTION, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50 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