BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P020050 · Supplement: S006 · Decision Nov 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    WAVELIGHT EX500 LASER SYSTEM
    PMA Number
    P020050
    Supplement Number
    S006
    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
    November 23, 2011
    Date Received
    April 4, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INCREASED PULSE FREQUENCY FROM 400 TO 500 HZ, A NEW LASER HEAD, A NEW HOUSING WITH GREATER INTEGRATION OF ACCESSORIES, MODIFIED LASER PULSE TEMPORAL PARAMETERS, NEW EYETRACKER, NEW SCANNER, REMODELED USER INTERFACE, ADDITION OF NETWORKING CAPABILITY, ANDMODIFIED SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME WAVELIGHT EX500 LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR:1) THE REDUCTION OR ELIMINATION OF MYOPIA OF UP TO -12.0 DIOPTERS (D) OF SPHERE AND UP TO - 6.0 D OF ASTIGMATISM AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D OF PREOPERATIVESPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY;2) THE REDUCTION OR ELIMINATION OF HYPEROPIC REFRACTIVE ERRORS UP TO +6.0 D OF SPHERE WITH AND WITHOUT ASTIGMATIC REFRACTIVE ERRORS UP TO 5.0 D AT THE SPECTACLE PLANE, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF STABLE MANIFEST REFRACTION DEFINED AS<= 0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY, EXCLUSIVE OF CHANGES DUE TO UNMASKING LATENT HYPEROPIA;3) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 D AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND 4) THE WAVEFRONT-GUIDED (WFG) REDUCTION OR ELIMINATION OF UP TO -7.00 D OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -7.00 D OF SPHERICAL COMPONENT AND UP TO 3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D OF PREOPERATIVE SPHERICAL SHIFT OVER ONE YEAR PRIOR TO SURGERY.

    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