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510(k) Data Aggregation

    K Number
    K972695
    Device Name
    FINALLY FREE
    Manufacturer
    MEHL/GROUP MARKETING
    Date Cleared
    1997-10-22

    (96 days)

    Product Code
    KCX
    Regulation Number
    878.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEHL/GROUP MARKETING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FINALLY FREE Ultra tweezer-type epilator is indicated for the removal of unwanted body and facial hair. Like the predicated in the is specifically dosigned for use h is specifically designed for use by consumers.
    Device Description
    Finally Free Ultra is a tweezer-type epilator for the removal of unwanted body and facial hair. It is designed for consumer home use. The device removes hair by the application of radio frequency energy to the hair shaft, which in turn conducts it to the hair root. There the energy causes the root to separate from follicle, thereby causing the hair to fall out. Further damage to the surrounding tissue stunts hair growth. This patented process is called NU-Trolysis. Finally Free Ultra is substantially equivalent to Forever Free, another consumer-use tweezer-type epilator manufactured by Burke/Neutech (K952117). Both are plastic encased units which plug into a standard 110V wall socket and which convert the AC current into radio frequency energy by means of a crystal oscillating component and both amplifying and filtering circuitry. The energy is delivered by a line cord attached to a hand-held wand with a tweezer which grasps the individual hair.
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