FDAnews
www.fdanews.com/articles/67193-fda-clears-gentlewaves-to-treat-periorbital-wrinkles-rhytids

FDA CLEARS GENTLEWAVES TO TREAT PERIORBITAL WRINKLES, RHYTIDS

January 5, 2005

Light BioScience has announced that the FDA cleared GentleWaves Light Emitting Diode (LED) Photomodulation System for the noninvasive 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, according to the company.

The device uses specially coded arrays of light emitting diodes to modulate the activity of living cells. GentleWaves' exclusive core technology delivers very low-intensity, nonthermal 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.