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510(k) Data Aggregation

    K Number
    K101713
    Device Name
    LIPCOLLECTOR II
    Manufacturer
    HUMAN MED AG
    Date Cleared
    2010-06-29

    (11 days)

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

    HUMAN MED AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use: Aesthetic body contouring Intended use: Harvesting, filtering and transferring of autologous fat tissue
    Device Description
    The LipoCollector II complete set consists of an autoclavable polymeric tissue collection container with a stainless steel lid and pre-fillering basket, and a disposable set including mesh filters. O-rings and inner tubing. The LipoCollector II complete set also includes a stainless steel extraction cannula (single-use) for withdrawal of the collection container. From the extraction cannula, the fat can be directly transferred to a Luer-Locksyringe (not part of the LipoCollector !! complete set) for autologous fat transfer. The intended use of the LipoCollector II complete set is to filter and collect the aspirated fat tissue for subsequent transfer of the autologous fat into subcutaneous fat tissues during the same procedure.
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    K Number
    K082025
    Device Name
    BODY-JET
    Manufacturer
    HUMAN MED AG
    Date Cleared
    2008-08-13

    (27 days)

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

    HUMAN MED AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aesthetic body contouring
    Device Description
    The body-jet®, a suction lipoplasty system, is a device intended for aesthetic body contouring. The device consists of a powered vacuum pump (containing an overflow/bacterial filter in the tube between the vacuum pump and suction bag), a collection bag with integrated overflow/bacterial filter, cannulae, and a connecting tube. The suction/collection bags including bacterial filters, the tubing, and the cannulae are to be changed between patients. The powered vacuum pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 26.5 inches of mercury, vacuum control valve to regulate the vacuum with accompanying vacuum gauge, a double piston, and a safety trap. The powered vacuum pump generates a negative pressure for the removal of fat or adipose tissue from distinct body-fat deposits for aesthetic body-contouring. The body-jet® includes a sterile, single-use tubing set with a small infiltration pump (the WAL Applicator), which transports the saline for the infiltration of the tissue area to be treated, and infiltration and irrigation cannulae. The single-use tubing set (WAL Applicator) and the reusable cannulae have been designed as proprietary products.
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