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.