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Zeltiq CoolSculpting wins FDA clearance

Zeltiq, a global medical device company, has received US Food and Drug Administration (FDA) clearance for CoolSculpting, a procedure of non-invasive reduction of fat.

The CoolSculpting procedure, developed at the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, is based on extensive scientific research that demonstrates that fat cells are more susceptible to extreme cold and are selectively, painlessly and permanently destroyed by a process called Cryolipolysis (cold lipolysis).

Zeltiq said that CoolSculpting procedure results in a 20% reduction of fat in the treated area, and patients can start to see results as soon as three weeks following treatment, with the results occurring over a period of two to four months in most patients.

Zeltiq said that CoolSculpting involves no needles, surgery or downtime where a non-invasive applicator delivers precisely controlled cooling to the treatment area to specifically target underlying fat, leaving surface skin tissue unaffected and is done in two to four months.

Yale University School of Medicine associate clinical professor of dermatology, board certified dermatologist and co-director of SkinCare Physicians Jeffrey Dover said that CoolSculpting is an exciting new approach that is non-invasive and has shown significant, durable, and reliable results in clinical studies for removing fat without the potential risks and downtime of invasive procedures.