i-lipo is the latest non-invasive body contouring procedure to receive FDA marketing clearance. It now joins the ranks of Liposonix, Cellulaze, Zeltiq, Zerona and many other devices that are for vying for their share of this ever-expanding market.
The FDA has cleared the i-lipo low-level laser diode device for circumferential reduction. According to device manufacturer Chromogenex, this makes it the first direct skin contact laser device to receive FDA clearance for this indication.
i-lipo emits low levels of laser energy, which creates a chemical signal in the fat cells, breaking down the stored triglycerides into free fatty acids and glycerol, and releasing them though channels in the cell membranes. The fatty acids and glycerol are then transported around the body to the tissues that will use them during metabolism to create energy. A period of exercise post treatment ensures the complete metabolism and elimination from the body of the freed fatty acids, the manufacturer states.
In the study that led to FDA clearance, more than 70 percent of participants experienced significant inch loss. The results represented more than double the percentage difference for meeting significant results as defined by the FDA.
The study’s success criterion was a minimum reduction of 1.57 inches from the waist circumference. Fifteen of the 19 test participants and one of the 15 individuals who received a sham treatment reached this goal. The treatment group received 8 20-minute laser treatment sessions over a 3 to 4 week period. Each session was followed by post-treatment exercise. The control group undertook an identical scheduling and exercise program using a sham light diode device.
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