BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970043 · Supplement: S021 · Decision Oct 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    ALCON LADARVISION 4000 EXCIMER LASER SYSTEM-
    PMA Number
    P970043
    Supplement Number
    S021
    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
    October 14, 2005
    Date Received
    September 26, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SOFTWARE CALIBRATION "LOCK-OUT" FEATURE WHERBY THE LASER SYSTEM WILL BE "LOCKED-OUT" TO PREVENT THE INITIATION OF SURGERY MORE THAN 60 MINUTES AFTER THE LAST SYSTEM CALIBRATION, A "COUNTDOWN CLOCK" ON THE COMPUTER MONITOR WHICH WILL PROVIDE THE USER WITH FEEDBACK ON THE REMAINING TIME BEFORE THE SYSTEM WILL LOCK-OUT, AND A SOFTWARE BUG FIX TO CORRECT A CERTAIN "BUG" FROM OCCURRING UNDER CERTAIN CONDITIONS IF THE RULER TOOL WAS USED WITH THE TRACKER ENGAGED DURING SURGERY.

    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