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510(k) Data Aggregation

    K Number
    K101413
    Device Name
    EUROMI EVA SP6
    Manufacturer
    EUROMI SA
    Date Cleared
    2010-12-16

    (210 days)

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

    EUROMI SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used for aesthetic body contouring.
    Device Description
    The subject device is used in conjunction with the Lipomatic Handpiece. The Lipomatic Handpiece is a motorized pneumatic handle with interchangeable canulae. The Lipomatic handpiece can be used with readily available air sources at the hospital or clinic. The EVA sp6 is an aspiration system that can be used with the Lipomatic handpiece for the purposes of aesthetic body contouring. The EVA sp6 can be in continuous operation or can be controlled by a foot pedal. The device has two modes; infiltration and aspiration. Syringes are used for infiltration. The EVA sp6 has wheels to allow it to move around the clinical or hospital as needed. The list of accessories include: - Pedal . - . Hospital Grade Power Cord and Plug - Replacement Fuses . - Tubing (5 kits) . - Twisted Pipe of 5 meter with one connector . - Aspiration Jars (2 jars) .
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    K Number
    K010311
    Device Name
    LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE
    Manufacturer
    EUROMI SA
    Date Cleared
    2001-06-29

    (148 days)

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

    EUROMI SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject device is intended to be used for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.
    Device Description
    The subject device consists of: - Lipomatic Control Unit - Tubing - Key for the Lipomatic Control Unit - Oil - Silicone Pipe - Lipomatic Cannulas - Handle with a pneumatic motor - Collection Container - Pedal The handpiece is a motorized pneumatic handle with interchangeable cannulas. The motor is linear and not rotary. The subject device uses external air sources. Therefore, the user chooses the air source and filtration system from readily available sources within a hospital or clinical environment. The Lipomatic does not include an aspirator or compressor. The subject device includes either stainless steel or Teflon coated cannulas (based on customer order) that vary in length between 150mm-350mm and vary in diameter between 2.5mm-4.5mm. The subject device has a built in safety feature which stops the device in the event hard tissue is encountered.
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