WONTECH, a South Korean laser and energy based medical aesthetic device company, has announced that its LLLT hair loss treatment device, HairBoom Air, secured the 510(K) clearance from the US Food and Drug Administration.
The FDA approved the HairBoom Air as a Class II for hair treatment medical device.
This approval marks the second FDA clearance for hair loss medical devices since the approval of ‘HairBoom’ in 2018.
HairBoom and HairBoom Air hair loss medical devices are known in Korea as ‘Hairbeam’ and ‘Hairbeam Air’.
Although many medical devices for hair loss treatment are composed of LD (Laser Diode) and LED terminal combinations, HairBoom Air has 69 LD terminals.
The latest model of the hair boom series, HairBoom Air uses a safe low-power laser therapy (LLLT).
The laser produced from the LD terminal is examined evenly throughout the scalp to activate follicle cell proliferation, boost blood flow, and supply nutrition and oxygen to the hair muscles for smooth blood flow. This is essential to create healthy hair and strengthen the thickness of hair.
HairBoom Air can manage the entire scalp and is easy to use because it is lighter helmet-type compared with earlier devices.
WONTECH chief of US branch Seung-woo Song said, “In Korean market, WONTECH ‘s HairBoom Air is on unrivaled position as hair loss treatment devices, but we have prepared products that are more competitive. Also, as the overall U.S. market for hair loss treatment is huge, the FDA clearance of this new product is very meaningful in order to enter the global market.”
