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The Intended use for this product is to remove unwanted hair.

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The sole indication for use of this medical device is as an epilator for the removal of undesired body hairs using the techniques described in the Owner's Instruction Brochure.

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For the removal of hair

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.

For the removal of hair

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.

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.

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.

The sole indication for use of this Class III Tweezer-Type Epilator medical device is for the removal of undesired body hairs using the techniques described in the Owner's Instruction Brochure.

Class III Tweezer-Type Epilator