FDA Clears Body-Contouring Laser Treatment

Yael Waknine

October 04, 2010

October 4, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for noninvasive and painless laser treatment (i-Lipo Ultra; Zone Life) that can reduce the appearance of cellulite and help slim specific body areas during a short period.

Common treatment areas include the flank (known as "love handles"), abdomen, thighs, stomach, buttocks, and chin.

For each treatment session, low-level laser light is delivered to problem areas via 4 pads placed directly on the skin for approximately 10 to 20 minutes. The light is absorbed into individual adipose cells, temporarily opening cell wall pores to release fat that is then collected by the lymphatic system and transported to body areas where it can be dissolved and released during exercise.

A 20- to 30-minute session of cardiovascular-related exercise is recommended immediately after each session but can be performed up to 12 hours later if necessary; 8 to 10 sessions during a 4-week period are advised for optimal results.

According to a company news release, the relatively short amount of time required to achieve desired results may help motivate clients to adhere to a regular exercise regimen and healthy diet. The device is being launched in medical, spa, and fitness settings throughout the United States.

As previously reported by Medscape Medical News, the FDA also recently cleared a cryosurgical device (CoolSculpting; Zeltiq Aesthetics Inc) for the spot reduction of love handles and a cold body-sculpting laser (Zerona; Erchonia Medical Inc) for the circumferential reduction of the waist, hips, and thighs.


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