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SculpSure receives CE Mark approval

Cynosure announced in a press release that it has received European Medical Device Directive certification for its SculpSure hyperthermic aesthetic laser treatment for noninvasive fat reduction.

The certification from Cynosure’s European Notified Body, Intertek Semko AB, will allow Cynosure to place the CE Mark on SculpSure to distribute throughout member states of the European Union, according to the release.

“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,” Michael Davin, Cynosure chairman and CEO, said in the release.

Cynosure announced in May it received 510(k) clearance from the FDA to market SculpSure for noninvasive lipolysis of the abdomen.

SculpSure noninvasively reduces fat by disrupting subcutaneous fat cells, according to Cynosure.

Initial product sales are expected to begin in the fourth quarter of 2015 in the United States and Europe, according to the release.

Reference: www.cynosure.com