BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930016 · Supplement: S044 · Decision May 6, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM
    PMA Number
    P930016
    Supplement Number
    S044
    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
    May 6, 2015
    Date Received
    November 10, 2014
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    15M-1707

    Advisory Committee Statement

    APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM. THIS DEVICE USES A 6.0 MM OPTICAL ZONE, AND 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) IN PATIENTS:1) WITH MYOPIA AS MEASURED BY THE IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM UP TO -11 D SPHERICAL EQUIVALENT WITH UP TO -5 D CYLINDER; AND2) WITH AGREEMENT BETWEEN MANIFEST REFRACTION (ADJUSTED FOR OPTICAL INFINITY) AND IDESIGN ADVANCED WAVESCAN STUDIO SYSTEM REFRACTION AS FOLLOWS:1) SPHERICAL EQUIVALENT: MAGNITUDE OF THE DIFFERENCE IS LESS THAN 0.625 D; AND 2) CYLINDER: MAGNITUDE OF THE DIFFERENCE IS LESS THAN OR EQUAL TO 0.5 D; A) 18 YEARS OF AGE OR OLDER; AND B) WITH REFRACTIVE STABILITY (A CHANGE OF ¿ 1.0 D IN SPHERE OR CYLINDER FOR A MINIMUM OF 12 MONTHS 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