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510(k) Data Aggregation

    K Number
    K130152
    Device Name
    HYDRASOLVE LIPOPLASTY SYSTEM
    Manufacturer
    ANDREW TECHNOLOGIES, LLC
    Date Cleared
    2013-04-18

    (86 days)

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

    ANDREW TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydraSolve™ Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring. Adipose tissue harvested with the HydraSolve™ Lipoplasty System may be used for autologous transfer following the method provided in the manual.
    Device Description
    The Andrew Technologies HydraSolve "" Lipoplasty System is a liposuction system used to perform body contouring. It is designed to perform selective tissue extraction through a cannula that utilizes pressurized, heated, and pulsed saline solution to suction. Adipose tissue aspirated with the HydraSolve™ Lipoplasty System can be harvested for subsequent autologous transfer. The device includes the HydraSolve™ Console which contains within its durable case: a user interface, controller, power supply, and Phaser™ energy transfer systems (both heat and pressure). The system also includes a tumescent infusion component which is compatible with commercial off-the-shelf (COTS) turnescent cannulae and tubing. The device also includes the Sterile Treatment Kit consisting of a pumping mechanism, heat exchanger and tubing and a reusable limited-use handpiece with integral cannula. The device interfaces with COTS waste canisters and suction tubing.
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    K Number
    K121218
    Device Name
    HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
    Manufacturer
    ANDREW TECHNOLOGIES, LLC
    Date Cleared
    2012-12-13

    (234 days)

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

    ANDREW TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydraSolve™ Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring. The HydraSolve™ Lipoplasty System is Indicated for use in aesthetic body contouring.
    Device Description
    The Andrew Technologies HydraSolve™ Lipoplasty System is a liposuction system used to perform body contouring. It is designed to perform selective tissue extraction through a cannula that utilizes pressurized, heated, and pulsed saline solution in addition to suction. The device includes the HydraSolve™ Console which contains within its durable case. a user interface, controller, power supply, and Phaser™ energy transfer systems (both heat and pressure). The system also includes a tumescent infusion component which is compatible with commercial off-the-shelf (COTS) tumescent cannulae and tubing. The device also includes the Sterile Treatment Kit consisting of a pumping mechanism, heat exchanger and tubing and a reusable limited-use handpiece with integral cannula. The device interfaces with COTS waste canisters and suction tubing.
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    K Number
    K092066
    Device Name
    PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE
    Manufacturer
    ANDREW TECHNOLOGIES, LLC
    Date Cleared
    2010-04-12

    (278 days)

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

    ANDREW TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phaser Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring. The Phaser Lipoplasty System is indicated for use in aesthetic body contouring.
    Device Description
    The Phaser Lipoplasty System is a surgical liposuction device that utilizes pressurized, heated and pulsed saline streams ("the Phaser stream") in conjunction with a specialized cannula to transition adipose tissue from a solid state to a liquid or gel state so as to facilitate its removal from the body. The physician can employ standard surgical liposuction techniques when using the device, the low pressure and temperature allow adipose tissue removal without burning or otherwise damaging non-target tissues within the surgical field.
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