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

    LIPSONIX(R) SYSTEM MODEL 2

    K Number: K112626 · Decision Oct 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    41

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LIPSONIX(R) SYSTEM MODEL 2
    K Number
    K112626
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4590
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicis Technologies Corporation
    Date Received
    September 9, 2011
    Decision Date
    October 20, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OHV), ordered by most recent decision date.

    Ulthera® System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ulthera System (UC-1 Control Unit PRIME Model 2.1)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ulthera® System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SofWave System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ulthera System (UC-1 Control Unit PRIME)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SofWave System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Medicis Technologies Corporation

    K Number Device Name
    K100874 LIPOSONIX SYSTEM, MODEL 1 P00XXXX