VIRGINIA BEACH, Va. Light BioScience on Monday became the first company to receive a 510(k) over-the-counter clearance from the Food and Drug Administration for the treatment of periorbital wrinkles (wrinkles around the eye).
“This clearance paves the way for future development of a new anti-aging device to deliver the GentleWaves LED Photomodulation technology directly to the consumer marketplace without a prescription,” the company stated. "This … marks a significant milestone for our company as we continue to demonstrate our leadership in light-based science and break new ground in the medical professional and home-use markets," stated Rick Krupnick, Light BioScience chief executive officer. "The opportunity to develop the first FDA-cleared at-home, light-based device to treat wrinkles is just the first step in making this exciting technology more accessible to the public."
According to the company, GentleWaves has been scientifically proven to reduce the appearance of fine lines and wrinkles through the use of a patented system of pulsating amber-colored LEDs. These LEDs are specifically coded to stimulate collagen production while slowing down collagen breakdown, the company said.
Currently, Light BioScience is investigating the use of light therapy as a treatment for wound healing, radiation dermatitis, acne, thinning hair and ophthalmic disorders.
"Our on-going research reveals that the platform GentleWaves technology has the potential to treat or prevent a wide variety of medical conditions," Krupnick said.