BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P980008 · Supplement: S005 · Decision Sep 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
    PMA Number
    P980008
    Supplement Number
    S005
    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 28, 2001
    Date Received
    December 19, 2000
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    01M-0490

    Advisory Committee Statement

    APPROVAL FOR THE LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK). THE DEVICE IS INDICATED FOR LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM -0.5 TO LESS THAN -6.0 DIOPTERS (D) SPHERICAL EQUIVALENT, WITH ASTIGMATISM LESS THAN OR EQUAL TO 4.5 D, AS MEASURED AT THE SPECTACLE PLANE; 2) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D, OR <= 10% OF PREOPERATIVE SPHERICAL EQUIVALENT REFRACTION (SER) SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND, 3) IN PATIENTS WHO ARE 18 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