September 9, 2010
Zeltiq handed FDA clearance for fat reduction device
Zeltiq wins Food & Drug Administration 510(k) clearance for its CoolSculpting fat-cell-killing device that reduces love handles and other unwanted pockets of body fat.
Zeltiq landed 510(k) clearance from the Food & Drug Administration for its fat reducing device.
The Pleasanton, Calif. based medical device developer's CoolSculpting system works by cooling flabby tissue and leaving the skin's surface unaffected, the company said.
The initial research on the procedure, called cryolipolysis, was done at the Wellman Center for Photomedicine at Mass. General Hospital by Drs. Dieter Manstein and R. Rox Anderson, Zeltiq said. The doctors found that fat cells are more susceptible to extreme cold, meaning cells treated with the procedure would eventually die, resulting in the shrinkage of love handles, flanks or other flabby bits.
The CoolSculpting procedure permanently removes fat, although it is not intended for weight loss, according to the company. Zeltiq said its device is intended for the reduction of "pockets of fat that have not responded to a healthy lifestyle."
The procedure results in a loss of up to 20 percent of fat in the treated area, according to Zeltiq. The company said the system is immediately available at a nationwide network of clinics.