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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