FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

WONTECH Receives FDA Clearance for Hair Loss Device

Oct. 15, 2019
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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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