SculpSure receives FDA 510(k) clearance for non-invasive fat reduction

30 Jun 2015

Medical device manufacturer Cynosure has announced that its hyperthermic laser treatment device, SculpSure, has received 510(k) clearance from the Food and Drug Administration for non-invasive fat reduction.

The 510(k) clearance means that the company will now be able to market the device for the non-invasive treatment of fat.

Using a 1060 nm laser with a flexible applicator system to treat multiple areas of the body, Cynosure claims the SculpSure system works by disrupting subcutaneous fat cells.

"SculpSure represents an entirely new approach to non-invasive lipolysis, one that is safe and highly effective in reducing adipose tissue and does so in significantly less time than other current treatments," said Cynosure chairman and CEO Michael Davin.


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