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510(k) Data Aggregation

    K Number
    K022051
    Device Name
    SOUNDVASER SYSTEM
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Date Cleared
    2002-09-11

    (79 days)

    Product Code
    QPB,LFL,MUU
    Regulation Number
    878.5040
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K991791,K993868,K970471,K983065,K004005
    Why did this record match?
    Reference Devices :

    K991791, K993868, K970471, K983065, K004005

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

    • Neurosurgery -
    • Gastrointestinal and Affiliated Organ Surgery -
    • Urological Surgery -
    • Plastic and Reconstructive Surgery -
    • General Surgery -
    • -Orthopedic Surgery
    • Gynecological Surgery -
    • Thoracic Surgery -
    • -Laparoscopic Surgery

    The SoundVASER System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

    Device Description

    The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues.

    AI/ML Overview

    The provided text is a 510(k) summary for the SoundVASER System, which outlines its substantial equivalence to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria.

    Therefore, the document does not contain information on acceptance criteria, a study proving device performance against those criteria, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a test or training set.

    The document explicitly states: "The SoundVASER System is similar with regard to design, operation, materials, methods of sterilization, and intended use to the predicate devices indicated above. Therefore, no new safety or efficacy issues are created and the SoundVASER System is substantially equivalent to the predicate devices." This highlights that the submission relies on demonstrating substantial equivalence to already approved devices rather than presenting new performance data against acceptance criteria.

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