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Many traditional hair-removal procedures, such as waxing or shaving, can cause nicks, cuts and significant pain. As a practical matter, clearance often takes significantly longer as the FDA may require further information, including clinical data, to make a determination regarding substantial equivalence. Marketing and Distribution Channels. Equity compensation plans approved by security holders. Further Penetration of the Home Use Market.

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Contact Supplier. Radiancy believes the consumer market for aesthetic treatments represents a potential growth opportunity. Moreover, some of its competitors have developed, and others may attempt to develop, products with applications similar to those of Radiancy.

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Acne has proven to be a difficult condition to treat with traditional therapies, and thus far there have been limited options with a variety of side effects. Unless an exemption applies, each medical device Radiancy wishes to distribute commercially in the United States will require either prior k clearance or premarket approval from the FDA. Products for the Consumer Products Segment.

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The stimulation of new collagen growth occurs in response to a mild thermal insult in the reticular and papillary dermis. Radiancy operates its business through two principal business segments: Treatments for acne have historically been in the form of over-the-counter and prescription treatments including pills and topical ointments.