BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    CABOCHON SYSTEM

    K Number: DEN110004 · Decision Jul 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    620

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    Basic Information

    Device Name
    CABOCHON SYSTEM
    K Number
    DEN110004
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    878.4790
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Cabochon Aesthetics, Inc.
    Date Received
    October 31, 2011
    Decision Date
    July 12, 2013
    Product Code
    OUP
    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
    OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

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    Other Clearances by Cabochon Aesthetics, Inc.

    K Number Device Name
    K134010 CABOCHON SYSTEM