At-home hair growth device iGrow receives OTC clearance

BOCA RATON, Fla. — Apira Science announced on Tuesday that the FDA has granted the company OTC clearance for its iGrow Hair Growth System to promote hair growth in women with Fitzpatrick skin phototypes I to IV, and with Ludwig Baldness Scale Classifications of I to II.



The hands-free, in-home hair growth device is now widely available without a prescription for both women and men to effectively treat hair loss.



The iGrow uses low-level light therapy to increase hair counts by 37% among women in 16 weeks of treatments with zero side effects. According to the company, the device’s combination of medical-grade LEDs and red laser diodes offers a convenient, cost-effective and clinically proven solution for hair loss. With consistent use, both women and men with varying types and degrees of hair thinning and hair loss can experience significant results.



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% increase in hair counts in four months. The study added to the clinical study that showed a 35% increase in hair counts in men after 16 weeks of using iGrow. Both studies have been published in Lasers in Surgery in Medicine, a journal on laser-based technology.



The iGrow Hair Growth System is now available for purchase at www.igrowlaser.com; retail sites NeimanMarcus.com, Nordstrom.com, Hammacher.com, Drugstore.com and Frys.com; and at select Neiman Marcus, Nordstrom and Fry’s retail locations. The device comes with a six-month, money-back guarantee, and retails for $695.