2010 FDA (Food & Drug Administration) cleared a Laser device for hair growth in the treatment of female pattern baldness. ¬e MEP-90 Hair Growth Stimulation System received clearance according to the recently published 510(k) report, which reviewed the performance data of an IRB approved Clinical trial. Trial results cleared the device for the treatment of androgenetic alopecia, commonly referred to as female pattern baldness. ¬ It is the fi rst time a medical device has been cleared to promote hair growth in females. Previously, the FDA approved a hand held laser device for the treatment of male pattern baldness.
Clinical Data
For the MEP-90 case determination, each subject received a total of 36 separate 20 minute treatments over a period of 18 weeks.
Results were reviewed at the 10 week (20 treatment) and 18 Week (36 treatment) levels. 100% of the linear trend plotting for all subjects of their initial, 10 Week, and 18 Week hair counts demonstrated a historical rate of increased hair growth. Aft er the 36th treatment, 97% of the subject population demonstrated an increased hair count of = 20%. A total of 89% of all subjects demonstrated an increased hair count of = 30%, with 57% demonstrating an increased hair count of 50%.
Hair Loss Laser therapy is 100% safe and proven in over 3,500 scientific and medical papers over 30 years of research. Harvard University Massachusetts General Hospital (Harvard University) demonstrated development of healthy hair follicles through Laser Bio-Stimulation.
