BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060

    K Number: K133319 · Decision Mar 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    6
    Review Days
    143

    Basic Information

    Device Name
    ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
    K Number
    K133319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LUMENIS LTD.
    Date Received
    October 28, 2013
    Decision Date
    March 20, 2014
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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