The iGrow Hair Growth System from Apira Science (Boca Raton, FL) received the FDA green light for over-the-counter sale for women with Fitzpatrick skin phototypes I to IV and with Ludwig Baldness Scale Classifications of I to II.

The helmet, which includes a pair of headphones for listening to music or podcasts from your tablet or smartphone during at-home treatment, delivers red light to the scalp using lasers and light emitting diodes. The company terms this Low-Level Light Therapy (LLLT) and the system requires use for four to six months to get complete results.

From the announcement:

Apira Science earned FDA clearance by conducting a double-blind, independently reviewed clinical trial to test the efficacy and safety of the iGrow Hair Growth System to promote hair growth in women. Female participants used the iGrow four times per week for 25 minutes per session and saw a 37 percent increase in hair counts in just four months. The study, “The growth of human scalp hair in females using visible red light laser and LED sources,” adds to the award-winning clinical study that showed a 35 percent increase in hair counts in men after 16 weeks of using iGrow. Both studies have been published in Lasers in Surgery in Medicine, the gold-standard journal on laser-based technology.

Source:Apira Science