Studies on Laser Hair Loss Therapy
2010 FDA Cleared Device:
FDA (Food & Drug Administration) cleared a Laser device for hair growth in the treatment of female pattern baldness. ¬e MEP-90 Hair Growth Stiumlation System received clearance according to the recently published 510(k) report, which reviewed the performance
data of an IRB approved Clinical trial. E- 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.
For the MEP-90 e cacy 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 Th¬erapy is 100% safe and proven in over 3,500 scientific and medical papers and over 30 years of research.
Massachusetts General Hospital (Harvard University) demonstrated development of healthy hair follicles through Laser Bio-Stimulation.