BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970053 · Supplement: S010 · Decision Nov 8, 2006
    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
    PMA Number
    P970053
    Supplement Number
    S010
    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 8, 2006
    Date Received
    August 8, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE NIDEK EC-5000 EXCIMER LASER SYSTEM (MODEL CXII) INCLUDING A REDUCTION IN SIZE, THE STANDARDIZATION OF PREVIOUSLY OPTIONAL FEATURES, INCORPORATING THE CONTROL COMPUTER INTO THE COMPUTER (PREVIOUSLY STAND-ALONE) AND REPLACING THE ORIGINAL (MANUAL MAGNIFICATION) MICROSCOPE WITH A NEW MODEL WITH MOTORIZED MAGNIFICATION CONTROL. THE NEW DEVICE WILL BE NAMED THE NIDEK EC-5000 EXCIMER LASER SYSTEM MODEL CXIII.

    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