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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    LYSONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K980763
    Device Name
    LYSONIX LIPOPLASTY ACCESS PORT
    Manufacturer
    LYSONIX, INC.
    Date Cleared
    1998-05-28

    (90 days)

    Product Code
    QPB, OPB
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LYSONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LySonix Lipoplasty Access Port is indicated for use as an access portal to the surgical site and to reduce trauma to the incision site caused by removal and re-entry of cannulas during lipoplasty procedures during aesthetic body contouring.
    Device Description
    The LySonix Lipoplasty Access Port is an instrument access portal designed for use during lipoplasty procedures for aesthetic body contouring. The device is inserted into the incision site and threaded into place. Once in place, the device threads retain the device in place and allow for the insertion of the lipoplasty cannula. The Lipoplasty Access Portal is designed to be substantially equivalent to Endoscopic Access Devices intended to provide access for surgical instruments and to protect the incision site from trauma during repeated insertion of the cannula during surgical procedures.
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    K Number
    K980454
    Device Name
    LYSONIX ASPIRATION PUMP
    Manufacturer
    LYSONIX, INC.
    Date Cleared
    1998-03-18

    (41 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    LYSONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LySonix Aspiration Pump System is for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.
    Device Description
    The LySonix Aspiration Pump System is a stand-alone version of the aspiration component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.
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    K Number
    K974233
    Device Name
    LYSONIX IRRIGATION SYSTEM
    Manufacturer
    LYSONIX, INC.
    Date Cleared
    1998-02-03

    (83 days)

    Product Code
    GBX
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    LYSONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system. The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.
    Device Description
    The LySonix Irrigation System is a stand-alone version of the irrigation component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.
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    K Number
    K972958
    Device Name
    LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS
    Manufacturer
    LYSONIX, INC.
    Date Cleared
    1997-09-19

    (39 days)

    Product Code
    GCJ, FGY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LYSONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LySonix Cannulas are instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures.
    Device Description
    The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or spatula-shaped tip. The cannulas are provided with an attached handle. The Suction and Infusion Cannulas are each available in three cannula lengths and four diameters. The LySonix Suction/Aspiration and Infusion Cannulas will be provided non-sterile.
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