Cynosure, Inc. (NASDAQ: CYNO), a leader in laser- and light-based aesthetic treatments, today announced that it has received European Medical Device Directive (MDD) certification from its European Notified Body for SculpSure™, the world's first hyperthermic aesthetic laser for non-invasive fat reduction. The certification, from Intertek Semko AB, allows Cynosure to place the "CE" Mark on SculpSure for distribution in the European Union (EU) and its member states.
"The receipt of CE Mark approval is an important step in the commercialization of SculpSure in key European markets, and an integral element in our international growth strategy for this game-changing new device," said Cynosure Chairman and CEO Michael Davin. "The CE Mark validates product adherence to the European Commission's quality assurance and safety requirements. With the percentage of overweight adults in the European Region continuing to climb, we believe that millions of men and women in the region have the potential to benefit from this safe and effective treatment option."
SculpSure is FDA cleared in the United States for non-invasive lipolysis of the flanks and abdomen. Cynosure expects to begin initial product sales in the fourth quarter of 2015 both through its U.S. direct sales force and through its direct subsidiaries in France, Germany, Spain and the United Kingdom. In the EU, SculpSure will be debuted at the 24th European Academy of Dermatology and Venereology Congress, which takes place October 7-11 in Copenhagen, Denmark.