BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930016 · Supplement: S021 · Decision Aug 30, 2005
    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 VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
    PMA Number
    P930016
    Supplement Number
    S021
    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
    August 30, 2005
    Date Received
    March 8, 2005
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    05M-0382

    Advisory Committee Statement

    APPROVAL FOR THE STAR S4 IR EXCIMER LASER SYSTEM WITH VSS AND WAVESCAN WAVEFRONT SYSTEM. THE DEVICE USES A 6.0 MM OPTICAL ZONE, AN 8.0 MM TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA AND MYOPIC ASTIGMATISM FROM -6.0 TO -11.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER, AND 3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 1.00 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION.

    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