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Cynosure’s SculpSure gets FDA 510(k) approval for non-invasive lipolysis of abdomen

The US Food and Drug Administration (FDA) has granted 510(k) approval for Cynosure’s SculpSure for non-invasive lipolysis of the abdomen.

In May this year, Cynosure received FDA approval to market SculpSure for non-invasive lipolysis of the flanks.

Cynosure CEO Michael Davin said: "The abdomen and flanks are two areas of the body that are often difficult to target with diet and exercise alone, so the fact that SculpSure can now effectively treat both of these regions is great news for consumers.

"It’s also a significant achievement for our Company, demonstrating the initial breadth of our non-invasive fat reduction platform."

The company has developed SculpSure to reduce fat non-invasively by disrupting subcutaneous fat cells.

SculpSure includes flexible applicator system to treat multiple anatomical areas of the body and uses 1,060nm laser to treat an anatomical area in around 25 minutes.

The company intends to launch the new technology in the second half of this year.

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