BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970053 · Supplement: S008 · Decision May 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    NIDEK EC-5000 EXCIMER LASER SYSTEM
    PMA Number
    P970053
    Supplement Number
    S008
    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 28, 2004
    Date Received
    April 19, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO REPLACE THE 60HZ EYETRACKER WITH THE 200 HZ EYETRACKER IN THE NIDEK EC-5000 EXCIMER LASER SYSTEM FOR THE TREATMENT OF MYOPIA AND MYOPIC ASTIGMATISM.

    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