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FDA Grants Over-The-Counter Clearance to GentleWaves(R) for the First Home Use Light-Based Device to Treat Wrinkles
Date:2/25/2008

Clearance Opens Door For Home Use In The Anti-Aging Market

VIRGINIA BEACH, Va., Feb. 25 /PRNewswire-USNewswire/ -- Light BioScience(R), LLC, the leader in the science of LED (light emitting diode) Photomodulation, announced today that it has become the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for the treatment of periorbital wrinkles. This clearance paves the way for future development of a new anti-aging device to deliver the GentleWaves LED Photomodulation(R) technology directly to the consumer marketplace without a prescription.

Currently used by physicians around the world, 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(1). Invented by David H. McDaniel, M.D., director of the Institute of Anti-Aging Research and Assistant Professor of Clinical Dermatology and Plastic Surgery, Eastern Virginia Medical School, Virginia Beach, Va., the GentleWaves LED Photomodulation technology is a novel approach to provide skin rejuvenation without injuring the skin. GentleWaves is non-thermal, non-ablative and has no pain, side effects, or downtime.

"This clearance 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," comments Rick Krupnick, Chief Executive Officer of Light BioScience. "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."

The future of GentleWaves is even more promising as its benefits expand beyond the anti-aging arena. Currently the Company is investigating
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SOURCE Light BioScience, LLC
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