BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P990027 · Supplement: S010 · Decision May 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM
    PMA Number
    P990027
    Supplement Number
    S010
    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 18, 2010
    Date Received
    August 11, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES: 1) REMOVAL OF A REDUNDANT FLUENCE TEST;2) INTRODUCTION OF A NEW SCANNER SYSTEM FROM GSI TO THE LASER SYSTEM:3) EXTRAPOLATION OF THE WAVEFRONT DATA IN THE DIAGNOSTIC ZYWAVE SOFTWARE;4) NEW ZRS (ZYOPTIX REMOTE SUPPORT) SOFTWARE TO MONITOR THE PERFORMANCE OF THELASER AND DIAGNOSTIC DEVICES REMOTELY VIA THE INTERNET;5) MODIFICATION OF THE ZRS TO INCLUDE TRULINK, AN ENHANCEMENT TO THE ZRS SYSTEM;6) INTRODUCTION OF A NEW OP FIELD ILLUMINATION IN THE LASER SYSTEM;7) CHANGE OF THE VIDEO CHIP IN THE CCD LENSLET CAMERA DMK4002-IR; AND8) CHANGE IN THE SUPPLIER OF THE TEMPERATURE CONTROL UNIT IN THE LASER SYSTEM.

    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