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510(k) Data Aggregation

    K Number
    K980771
    Device Name
    LYSONIX SUCTION LIPOPLASTY SYSTEM
    Manufacturer
    LYSONIX, INC.
    Date Cleared
    1998-07-13

    (136 days)

    Product Code
    QPB,MUU,OPB
    Regulation Number
    878.5040
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LYSONIX SUCTION LIPOPLASTY SYSTEM

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

    The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.

    Device Description

    The LySonix Suction Lipoplasty System consists of an Aspiration Pump, Aspiration Cannulas, Sterile Tubing Set, Microbial Filter, Collection Canisters, and Canister Liners.

    AI/ML Overview

    The provided text is a 510(k) summary for the LySonix Suction Lipoplasty System, indicating FDA clearance based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, device description, and indications for use, without detailing specific performance metrics, clinical study designs, or acceptance criteria.

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