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FDA clears new laser hair treatment medical device

FDA clears new laser hair treatment medical device
FDA has cleared new laser hair growth device known as HairBoom Air according to a  press release of the company that has received approval.

Baldness typically refers to excessive hair loss from the scalp which is more common in men. Hair loss can be the result of heredity, hormonal changes, medical conditions or medications.

Laser Hair Growth Device, HairBoom Air

Laser Hair Growth Device, HairBoom Air

The U.S. Food and Drug Administration has cleared the HairBoom Air as a Class II for hair treatment medical device. This is the second FDA clearance for hair loss medical devices since the FDA cleared ‘HairBoom’ in 2018′.HairBoom Air’ is a U.S. market-friendly model for hair loss medical devices known in Korea as ‘Hairbeam’ and ‘Hairbeam Air’. While many medical devices for hair loss treatment are composed of LD (Laser Diode) and LED terminal combinations, HairBoom Air, which was cleared by the U.S. FDA, has 69 LD terminals.

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WONTECH, a leading Korean laser and energy based medical aesthetic device company has been granted approval for LLLT hair loss treatment device, HairBoom Air.

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These devices deliver nourishing laser energy to stimulate hair follicles, reverse thinning process, restore your natural growth cycle and regrow hair.

HairBoom Air is the latest model of the hair boom series and uses a safe low-power laser therapy (LLLT). The laser generated from the LD terminal is examined evenly throughout the scalp to activate follicle cell proliferation, increase blood flow, and supply sufficient nutrition and oxygen to the hair muscles with smooth blood flow to create healthy hair and strengthen the thickness of hair.

Based on the clinical results of equivalence, HairBoom Air has the advantage of being able to manage the entire scalp and easy to use because it is lighter helmet-type than previous devices.

Seung-woo Song, Chief of U.S branch, WONTECH said, “In the 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.

WONTECH is a rapidly growing company in the world of laser and energy-based medical devices. Established in 1999 as WONTECH Co., Ltd., the company has a diverse product lineup of 50 kinds of lasers, ultrasound, and radiofrequency products based on laser medical device technology.

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