BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970043 · Supplement: S019 · Decision May 1, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    LADAR 6000 EXCIMER LASER SYSTEM
    PMA Number
    P970043
    Supplement Number
    S019
    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 1, 2006
    Date Received
    November 30, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN THE LADARVISION 4000 SYSTEM INCLUDING A NEW CONFIGURATION OF THE ILLUMINATION SYSTEM, UPGRADES TO THE LASER COMPUTER AND OPERATING SYSTEM, AND VARIOUS OTHER HARDWARE AND SOFTWARE CHANGES INTENDED TO ADDRESS COMPLIANCE WITH EMI REQUIREMENTS, MANAGE COMPONENT OBSOLESCENCE, REDUCE MAINTENANCE REQUIREMENTS, AND ENHANCE ERGONOMIC AND USER INTERFACE FEATURES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADAR 6000 EXCIMER 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