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FDA OKs Unilever’s OTC Device for Wrinkles

August 31, 2012

• Cynosure, Inc. has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a home-use, over-the-counter device for the treatment of facial wrinkles. The device, which was developed in partnership with Unilever, is expected to debut in 2013.

“FDA clearance of this device marks a significant milestone in our alliance with Unilever to develop light-based devices for the consumer market,” said Michael Davin, Cynosure’s president and CEO of Cynosure, which is based in Westford, MA.”Our strategic partnership with Unilever blends our expertise in developing market-leading, light-based technology that emphasizes patient safety and clinical results, with Unilever’s unparalleled innovation, branded marketing and distribution.”

The device is indicated for the treatment of both periorbital and perioral wrinkles, according to Cynosure, which signed a multi-year funded cooperative development agreement with Unilever in June 2009.

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