BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CHROMOLITE EP

    K Number: K081619 · Decision Jul 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    2
    Review Days
    39

    Basic Information

    Device Name
    CHROMOLITE EP
    K Number
    K081619
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CHROMOGENEX TECHNOLOGIES LIMITED
    Date Received
    June 9, 2008
    Decision Date
    July 18, 2008
    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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    Other Clearances by CHROMOGENEX TECHNOLOGIES LIMITED

    K Number Device Name
    K111501 I-LIPO SYSTEM