FDA approves i-Lipo (Chromogenex) for Fat Reduction therapy

The FDA has cleared the i-Lipo low-level laser diode device, from Chromogenex, to market for circumferential reduction or Fat Reduction. The clearance is based on results from a double-blind, placebo-controlled, randomized study of 34 volunteers in which over 70% of participants experienced significant waist reduction. Of the 34 participants, 19 were randomly selected for the treatment group and 15 for the control. The treatment group received eight 20-minute laser treatment sessions, over a three to four week period, which were immediately followed by a period of post-treatment exercise. The control group undertook an identical treatment and exercise program using a placebo light diode device. 79% (15 of 19 participants) of the test group achieved and surpassed a reduction of 4.0cm (1.57 inches) from the circumference measurement of the waist, while only 6.7% (1 participant out of 15) of the control group achieved the target. This 72% difference between the two groups is more than double the percentage difference defined by the FDA as demonstrating a significant result from treatment. Comparison of the results demonstrated a mean difference between groups of 3.8cm (1.49 inches). It is believed that low levels of laser energy from the i-Lipo creates a chemical signal in fat cells, breaking down the stored triglycerides into free fatty acids and glycerol, and releasing them though channels in the cell membranes.