BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970043 · Supplement: S014 · Decision Sep 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    LADARVISION 4000 EXCIMER LASER SYSTEM
    PMA Number
    P970043
    Supplement Number
    S014
    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
    September 12, 2003
    Date Received
    August 21, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE TO BE USED WITH THE LADARVISION 4000 EXCIMER LASER SYSTEM WHICH WILL ALLOW TREATMENT PLANNING BY THE PRACTITIONER PRIOR TO THE ACTUAL DATE OF SURGERY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADARVISION 4000 EXCIMER LASER SYSTEM AND IS INDICATED FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE.

    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