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

    SOUND VASER SYSTEM

    K Number: K991791 · Decision Aug 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    6
    Review Days
    79

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    Basic Information

    Device Name
    SOUND VASER SYSTEM
    K Number
    K991791
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sound Surgical Technologies, LLC
    Date Received
    May 25, 1999
    Decision Date
    August 12, 1999
    Product Code
    LFL
    Advisory Committee
    Unknown
    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
    LFL Instrument, Ultrasonic Surgical

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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
    K022051 SOUNDVASER SYSTEM
    K993868 THE SOUNDVASER DISSECTION SYSTEM