Washington — The Food and Drug Administration has cleared the i-Lipo (Chromogenex), a low-level laser diode fat-reduction device for body contouring, for U.S. marketing.
PRNewswire reports that the FDA based its approval on results of a recent placebo-controlled, randomized study of 34 volunteers, 19 of whom were randomly selected for the treatment group and 15 for the control group. The treatment group received eight 20-minute laser treatment sessions over a three- to four-week period, followed by a period of post-treatment exercise. Members of the control group were treated for identical periods of time and undertook the same exercise program. Participants were unaware of their group allocations until the study was completed.
The success criterion for participants was to achieve a minimum reduction of 1.57 inches from the waist circumference. Fifteen of the 19 test participants reached the criterion, while one of the 15 placebo participants reached it.
According to Chromogenex, the U.K.-based developer and manufacturer, i-Lipo is the first direct contact laser device designed for fat reduction and body contouring to win FDA clearance for circumferential reduction.
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