FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

WONTECH Receives FDA Clearance for Hair Loss Device

Oct. 15, 2019

Korean devicemaker WONTECH received 510(k) clearance for its hair loss treatment device, the HairBoom Air.

The HairBoom Air uses low-power laser therapy to activate follicle cells and increase blood flow to promote hair growth. The lightweight helmet device can deliver treatment to the entire scalp.

WONTECH offers a wide range of lasers, ultrasound and radio frequency products based on laser medical device technology. The agency cleared the company’s original HairBoom product in 2018.

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