FDA clears Chromogenex i-Lipo laser diode device
The US Food and Drug Administration (FDA) has cleared Chromogenex Technologies' i-Lipo low-level laser diode device.
i-Lipo is a direct skin contact laser device which is designed for circumferential reduction of fat and body contouring.
The FDA clearance is based on results from a recent double-blind, placebo-controlled, randomized study which showed that over 70% of participants experienced inch loss, thus validating the use of i-Lipo to target specifically chosen anatomical areas for fat reduction.
Chromogenex Technologies CEO Peter McGuinness said the study supports previous studies completed in France and the UK and from results experienced by current i-Lipo devices already placed in over 1000 commercial clinics worldwide.
"This result from the FDA is extremely statistically significant and gives confidence of 99.99% that a participant undertaking i-Lipo will achieve a greater circumference reduction than a participant undertaking exercise alone in a three to four week period," McGuinness added.