BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930016 · Supplement: S014 · Decision Nov 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    VISX STAR EXCIMER LASER SYSTEM
    PMA Number
    P930016
    Supplement Number
    S014
    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 6, 2001
    Date Received
    June 4, 2001
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    01M-0522

    Advisory Committee Statement

    APPROVAL FOR THE VISX STAR S2 AND S3 EXCIMER LASER SYSTEMS. THE DEVICES ARE INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF NO MORE THAN 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; AND 2) IN PATIENTS 21 YEARS OF AGE OF OLDER IN TREATMENTS FOR THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM WHERE THE MAGNITUDE OF CYLINDER (<=6.0 D AT THE SPECTACLE PLANE) IS GREATER THAN THE MAGNITUDE OF SPHERE AND THE CYLINDER AND SPHERE HAVE OPPOSITE SIGNS.

    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