Cynosure hyperthermic laser treatment for noninvasive fat reduction receives FDA approval

Aesthetic laser maker Cynosure (Westford, MA) has received FDA clearance to market its SculpSure hyperthermic laser treatment for noninvasive lipolysis of the flanks.

Related: ASLMS presentations highlight Cynosure's laser lipolysis technology

SculpSure reduces fat noninvasively by disrupting subcutaneous fat cells, and features a flexible applicator system to treat multiple anatomical areas of the body. Using a 1060 nm laser, the device can treat an anatomical area in approximately 25 minutes. Patients are able to achieve desired results without downtime or surgery.

Abstracts presented at the 2015 American Society for Laser Medicine and Surgery (ASLMS) Annual Conference (held April 22-26, 2015, in Kissimmee, FL) featured clinical data from approximately 100 subjects treated with SculpSure in multicenter studies at two U.S. sites. Researchers saw statistically significant reduction in adipose layer thickness, six and 12 weeks post-treatment. The device is intended for individuals with a body mass index (BMI) of 30 or less.

Cynosure plans to introduce SculpSure through its U.S. direct sales force late in the second half of 2015.


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