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Cynosure’s SculpSure obtains CE mark approval for non-invasive fat reduction

Cynosure has received CE mark approval for its SculpSure, a hyperthermic aesthetic laser for non-invasive fat reduction.

The firm has obtained European Medical Device Directive (MDD) certification from its European Notified Body for SculpSure, allowing it to place the CE mark on the device for marketing in the European Union (EU) and its member states.

Cynosure chairman and CEO Michael Davin said: "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.

"The CE mark validates product adherence to the European Commission’s quality assurance and safety requirements."

In July, the company received 510(k) approval from the US Food and Drug Administration (FDA) for SculpSure for non-invasive lipolysis of the flanks and abdomen.

Cynosure intends to begin the commercial distribution of the product in the US and European countries such as France, Germany, Spain and the UK from the fourth quarter of this year.

The company will exhibit the SculpSure at the 24th European Academy of Dermatology and Venereology Congress, which will be held in Copenhagen, Denmark, from 7 to 11 October.

Cynosure develops and markets medical devices for aesthetic procedures and precision surgical applications across the globe.