BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970043 · Supplement: S026 · Decision Nov 1, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE
    PMA Number
    P970043
    Supplement Number
    S026
    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 1, 2006
    Date Received
    September 28, 2006
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SOFTWARE CHANGE TO THE WAVEFRONT-IMAGE GATHERING SEQUENCE IN THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE TO ALLOW FOR DIFFERENT PRE-OP AND SURGERY DAYS; A CHANGE TO THE LADAR6000 SOFTWARE TO ALLOW FOR CONVENTIONAL CENTRATION PHOTOS TO BE IMPORTED FROM THE LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM; AND, MINOR ENHANCEMENTS/BUG FIXES TO THE LADARVISION 4000 SOFTWARE, THE LADAR6000 SYSTEM SOFTWARE, AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE.

    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