[By NBC-1TV H. J Yook]Apira Science, Inc. (www.igrow2laser.com), a global leader in aesthetic light-based therapies, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its iGrow® Hair Growth Platform. This patented red light technology device is now FDA cleared for the treatment of androgenetic alopecia (male pattern hair loss). This system treats affected areas of the scalp, requires no manual movement, and is the first hands-free Low Level Laser Therapy (LLLT) hair growth device cleared by the FDA for use at home.
“This landmark achievement represents a significant and strategic milestone for Apira Science. The iGrow platform provides effective LLLT treatment that was previously only available in a professional setting. This safe and effective treatment for androgenetic alopecia offers significant advantages over other LLLT devices currently on the market, and will forever change the way men's hair loss is treated,” said Nicholas Brox, president and CEO, Apira Science, Inc. “We have invested in innovative engineering and applied science to develop an effective light-based hair growth system that consumers can use in the privacy of their homes.”
Low-level laser hair growth therapy is rapidly becoming widely accepted as an alternative to drugs and surgery. Male pattern hair loss affects a large portion of the male population according to The International Society of Hair Restoration Surgery. They estimate that that over 35 million men in the US are afflicted with this condition. The onset of male pattern hair loss can begin in the late teen years and progress over a lifetime.
Products that address the in-home device market for LLLT hair growth are expected to grow exponentially through the continued introduction of effective and convenient treatments.
“The iGrow platform utilizes non-invasive, low-level red laser and LED light to effectively re-energize the unhealthy cells that are in and around the hair follicle,” said Jeff Braile, president, medical device division, Apira Science, Inc. “We designed this platform to optimize all that is scientifically known about LLLT for hair growth. The results from our recently completed study unequivocally proved the effectiveness of the iGrow's low-level laser therapy in the treatment of androgenetic alopecia.”







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