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

    LIPOSONIX SYSTEM, MODEL 1 P00XXXX

    K Number: K100874 · Decision Aug 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    507

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    Basic Information

    Device Name
    LIPOSONIX SYSTEM, MODEL 1 P00XXXX
    K Number
    K100874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4590
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicis Technologies Corporation
    Date Received
    March 30, 2010
    Decision Date
    August 19, 2011
    Product Code
    OHV
    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
    OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

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    Other Clearances by Medicis Technologies Corporation

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