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510(k) Data Aggregation

    K Number
    K973174
    Device Name
    SONIQUE HAIR REMOVER
    Manufacturer
    GLOBAL TV CONCEPTS, LTD.
    Date Cleared
    1997-10-30

    (66 days)

    Product Code
    KCX
    Regulation Number
    878.5360
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the removal of hair
    Device Description
    The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
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    K Number
    K973179
    Device Name
    FEMINIQUE SONIC HAIR REMOVER
    Manufacturer
    GLOBAL TV CONCEPTS, LTD.
    Date Cleared
    1997-10-30

    (66 days)

    Product Code
    KCX
    Regulation Number
    878.5360
    Why did this record match?
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    Matched: '878.5360'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the removal of hair
    Device Description
    The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
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    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
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    Matched: '878.5360'

    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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