Light BioScience announced today that the U.S. Food and Drug Administration (FDA) cleared GentleWaves Light Emitting Diode (LED) Photomodulation System for the non-invasive treatment of periorbital (eye area) wrinkles and rhytids.
GentleWaves is the first and only LED device to receive marketing approval for a medical claim associated with cosmetic improvement of aging and sun-damaged skin, further validating the science of LED Photomodulation for skin rejuvenation.
"GentleWaves LED Photomodulation is a fundamentally new approach to improving photoaging and environmentally damaged skin that does not rely on high-energy sources and heat damage to photoactivate collagen genes," said Robert A. Weiss, MD, associate professor of dermatology at Johns Hopkins University School of Medicine in Baltimore, Maryland. "For the first time, we are both slowing down collagen breakdown and building up new collagen with no pain, no redness and no serious side effects. GentleWaves' unique ability to stimulate and/or inhibit cell signaling pathways for skin rejuvenation truly represents the next frontier in anti-aging medicine," added Dr. Weiss.
GentleWaves uses specially coded arrays of light emitting diodes to modulate the activity of living cells. Unlike other laser, pulsed light or radiofrequency techniques used today for skin rejuvenation, GentleWaves' exclusive core technology delivers very low-intensity, non-thermal light energy to stimulate collagen and reverse the appearance of photoaging. With its proprietary and predetermined energy sequencing, the easy-to-use device poses no learning curve or risk of complications. A patient simply sits with his/her face exposed to two panels of over 2,000 yellow cascading LED lights for less than one minute. The device can also be adjusted to treat the neck and chest areas. And, for patients seeking a full program of skin fitness, GentleWaves treatment is complemented by a scientifically developed line of cosmeceutical products.