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FDA Grants Over-The-Counter Clearance To GentleWaves(R) For The First Home Use Light-Based Device To Treat Wrinkles
Light 
BioScience(R), LLC, the leader in the science of LED (light emitting diode)   
Photomodulation, announced 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 new 
treatments 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," adds Krupnick. "Light BioScience is committed to investing in 
research and development so that we can bring these expanded applications 
to the medical community as well as to the consumer marketplace."
 
    
In 2003, Light BioScience created a new way for dermatologists and  
plastic surgeons to approach anti-aging and skin rejuvenation with the 
introduction of its flagship product, the GentleWaves LED Photomodulation 
System. Today, LED technology has become one of the most popular cosmetic 
treatments offered by doctors and estheticians worldwide.
 
    
"GentleWaves LED Photomodulation is a very useful new tool for cosmetic 
surgeons to reduce wrinkles in a rapid, safe and truly painless manner," 
explains Dr. McDaniel. "The ability to extend this therapy for use in the 
home without a reduction in benefits is a significant advancement in 
treating aging skin. The most exciting part of this development may 
ultimately be the interest that has been stimulated by the science and 
theory of Photomodulation discovered during the research and development of 
the GentleWaves device. Physicians and scientists worldwide are now 
exploring how very low energy light interacts with not just skin, but all 
living cells in the body. I expect many new applications for the 
GentleWaves technology in the future - this is only the beginning of what 
will be possible for both home and medical light therapies."
 
    
Tina Alster, M.D., director of the Washington Institute of Dermatologic 
and Laser Surgery in Washington, D.C. comments, "GentleWaves(R) offers 
superior rejuvenation compared to applying Retinoic Acid, but without the 
potential irritation."
 
    
About GentleWaves LED Photomodulation
    
Quick and convenient for today's fast-paced world, GentleWaves has been 
clinically proven to reduce fine lines and wrinkles without pain, redness, 
peeling or downtime. Users spend less than one minute sitting in front of a 
cascading array of amber colored pulsating lights. Because LED 
Photomodulation is a non-thermal, photo-biochemical process, it is one of 
the only technologies now available to safely treat all skin types 
resulting in noticeably softer, smoother and healthier-looking skin.
 
    
About Light BioScience, LLC
    
Light BioScience, LLC is the leader in the science of Light-Emitting 
Diodes (LED) Photomodulation, a groundbreaking light-based technology for 
medical and aesthetic applications. Its flagship product, the GentleWaves  
LED Photomodulation System, provides a safe and effective nonablative 
solution to photoaging. This non-thermal, non-invasive technology uses low 
intensity LEDs at specially calibrated energies to reduce the visible signs 
of aging and sun-damaged skin.
 
    
The company is actively researching other applications of the unique  
GentleWaves platform technology, including treatment protocols for the 
control of radiation dermatitis, the treatment of acne, thinning hair, and 
ophthalmic disorders. Based in Virginia Beach, VA, Light BioScience was 
founded in 2002 and now has more than 17 issued patents and 60 pending in 
the U.S.A. and worldwide. GentleWaves is currently used in hundreds of 
physician offices and medi-spas worldwide and has been clinically tested 
and shown to be safe and effective.
 
    
Dedicated to science and research, the company is continuing it's 
testing of a variety of new technologies to expand offerings to the medical 
and consumer markets.
 
    
For more information on Light BioScience and its products, visit Light 
BioScience's website at http://www.lightbioscience.com.
 
    
(1) Robert A. Weiss M.D., David H. McDaniel, M.D. Roy G. Geronemus, 
M.D., Margaret A. Weiss M.D, "Clinical Trial of A Novel Non-Thermal LED 
Array for Reversal of Photoaging: Clinical, Histologic, and Surface 
Profilometric Results," Lasers in Surgery Medicine, 2005 and Robert A. 
Weiss M.D., David H. McDaniel, M.D., Margaret A. Weiss M.D., Roy G. 
Geronemus, M.D., Karen L. Beasley, Girish M. Munavalli, M.D., Supriya G.    
Bellew, M.D., "Clinical Experience With Light-Emitting Diode (LED) 
Photomodulation(R)," The American Society for Dermatologic Surgery, 2005.
  
Light BioScience, LLC
http://www.lightbioscience.com
		
FDA Granturi printr-clearance-ul pentru a GentleWaves (R) Pentru prima utilizare acasã lumina pe baza de dispozitiv pentru a trata riduri - FDA Grants Over-The-Counter Clearance To GentleWaves(R) For The First Home Use Light-Based Device To Treat Wrinkles - articole medicale engleza - startsanatate