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510(k) Data Aggregation

    K Number
    K053611
    Device Name
    SMOOTHSHAPES
    Manufacturer
    BICELLULASE, INC.
    Date Cleared
    2006-03-15

    (78 days)

    Product Code
    NUV
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BICELLULASE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biocellulase SmoothShapes device is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local hlood circulation, and temporary reduction in the appearance of cellulite.
    Device Description
    The SmoothShapes system consists of a main console unit and an applied part (massage head with rollers) which is connected to the main console by an umbilical. The main console unit contains the powersupply, hardware, transformers, fuses, cooling fan, mains-input connection, and the key-switch. The massage head, which is placed against the patient's skin, contains the rollers, LEDs, and laser diodes. The massage head rollers are mobilized in rotation and sliding back and forth. The patient massage is generated by the vacuum introduced to skin fold between the two rollers. The rollers in combination with the vacuum manipulate and smooth out the skin which facilitates tissue mobilization. The laser light provides topical heating which increases tissue temperature.
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