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

    SOUNDVASER SYSTEM

    K Number: K022051 · Decision Sep 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    57
    Applicant Total
    6
    Review Days
    79

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    Basic Information

    Device Name
    SOUNDVASER SYSTEM
    K Number
    K022051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sound Surgical Technologies, LLC
    Date Received
    June 24, 2002
    Decision Date
    September 11, 2002
    Product Code
    QPB
    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
    QPB System, Suction, Lipoplasty For Removal

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    Other Clearances by Sound Surgical Technologies, LLC

    K Number Device Name
    K120328 ORIGINS LIPOHARVESTING SYSTEM
    K110306 SOUND SURGICAL VASER 2.1 LIPO SYSTEM
    K110255 SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
    K993868 THE SOUNDVASER DISSECTION SYSTEM
    K991791 SOUND VASER SYSTEM