BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P990027 · Supplement: S013 · Decision Nov 4, 2009
    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
    S013
    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 4, 2009
    Date Received
    October 1, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SOFTWARE CHANGES INTRODUCED IN SOFTWARE VERSION 4.23A THAT AFFECTED THE ERROR MESSAGE DISPLAYS DURING THE CONDITIONING, ENERGY VERIFICATION, ANDTREATMENT PHASES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETECHNOLAS T217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISION CORRECTION AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR THE REDUCTIONOR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00D AND CYLINDER UP TO -3.00D AND MRSE <=7.50D AT THE SPECTACLE PLANE.

    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