iGrow Hair Growth System Approved by FDA for OTC Sales
The iGrow Hair Growth System, a device the company claims to promote male hair growth, won FDA clearance last week for over-the-counter sales.
The Boca Raton, Fla.–based iGrow says laser-technology device is intended for men whose hair loss patterns fall in a range between a receding hairline to a medium-sized bald spot in the middle of the head. The hands-free, helmet-like device reportedly demonstrated a 39 percent boost in hair growth in one clinical trial, the company’s website says.
The device uses non-invasive low-level laser therapy to strengthen hair follicles and generate cellular rejuvenation, the company said, adding that there are no side effects.
The iGrow is to be used for three to four non-consecutive days a week, the website says, which in turn will result in gradual hair growth over a 16- to 24- week period. The company, however, notes that individual results may vary.
The device sells for $695 and is available through the company’s website or select retail stores. — Kellen Owings
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.