FDA OKs Unilever’s OTC Device for Wrinkles

“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.

According to the research firm Medical Insight, worldwide sales of home-use aesthetic devices are expected to grow at a compound annual rate of 12.3% from $740.4 million in 2011to more than $1.3 billion in 2016.In North America, Medical Insight estimates the home-use category is expected to grow by a compound annual rate of 12.1% from $451.6 million in 2011 to approximately $800 million by 2016.

Cynosure signed a multi-year funded cooperative development agreement with Unilever in June 2009 to develop and commercialize light-based devices targeting the home use personal care market.