iGrow® Hair Growth System Receives FDA Over the Counter Clearance For Women

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“I wanted to share this recent press release about the iGrow® receiving FDA clearance for women…”

The system is the first wearable, in-home, low-level laser therapy (LLLT) hair growth device to receive a U.S. FDA OTC clearance for both men and women. fda_510k_cleared_bug_v4

BOCA RATON, Fla., December 15th — Apira Science, Inc. today announced the FDA has granted the company over-the-counter (OTC) clearance for its iGrow® Hair Growth System to effectively 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.

Apira will showcase the iGrow Hair Growth System at CES in Las Vegas on January 6-9, 2015 (booth #75708) demonstrating how the system’s patented red light technology re-energizes cells at the follicle level to effectively regrow thicker, fuller, and healthier hair. The iGrow uses low-level light therapy (LLLT) to increase hair counts by 37 percent among women in just 16 weeks of treatments with zero side effects. The device’s highly productive 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.

“More than 40 million women suffer from genetic hair loss, yet iGrow is one of just a handful of solutions the FDA has cleared for treating women,” said Jeff Braile, president of the Medical Products Division at Apira Science, Inc. “iGrow is the only home-use, hands-free device to be cleared by the FDA for both men and women. This puts it in an elite category of hair loss products proven equally effective for both men and women, and enables anyone to effectively treat hair loss from the comfort and privacy of their own home.”

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.

About Apira Science, Inc. – Apira Science, Inc. has pioneered low-level light therapy (LLLT) for over a decade. Its iGrow Hair Growth Platform draws on its expertise and innovations in the application of LLLT to deliver a simple, safe, and effective hair growth treatment. iGrow is a registered trademark of Apira Science, Inc.

iGrow Display HiRes Reading couch Women

iGrow’s® proprietary Low-Level Light Therapy (LLLT) technology utilizes a highly effective combination of red laser and LED light diodes to effectively stimulate and energize cellular activity causing an uptake in the natural function of the hair follicle. This proven 4 to 6 month process reverses hair thinning/loss, and effectively grows new healthy hair that is thicker, fuller and more vibrant.

  • Low-Level Laser Technology Energizes Hair Follicles 

  • Safe and Effective

  • Results in 4-6 Months

  • For more information on the iGrow® and Low-Level Light Therapy (LLLT), visit www.tmhair.com.
  • To find out if you are a viable candidate for Laser Therapy, visit www.tmhair.com or call 713-838-1880 to schedule a free consultation.