BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P990027 · Supplement: S002 · Decision May 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    TECHNOLAS 217A EXCIMER LASER SYSTEM
    PMA Number
    P990027
    Supplement Number
    S002
    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 17, 2002
    Date Received
    November 24, 2000
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    02M-0299

    Advisory Committee Statement

    APPROVAL THE TECHNOLAS 217A EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -12.00 D MRSE, WITH SPHERE BETWEEN >-7.00 D TO -10.99 D AND CYLINDER BETWEEN 0.00 AND <-3.00 D; 2) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION; AND, 3) IN PATIENTS WHO ARE 21 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