BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P990027 · Supplement: S007 · Decision Mar 15, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
    PMA Number
    P990027
    Supplement Number
    S007
    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
    March 15, 2006
    Date Received
    September 10, 2004
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) AN INCREASE IN THE LASER PULSE REPETITION FREQUENCY FROM THE CURRENT 50 HZ TO 100 HZ; 2)REPLACEMENT OF THE CERATUBE MIDI V.4.1 LASER WITH THE CERATUBE MIDI V.5.2 LASER; 3) SOFTWARE REVISIONS TO ACCOMMODATE THE NEW LASER AND PULSE RATE; 4) LABELING CHANGES TO DOCUMENT THESE MODIFICATIONS.

    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