FDAnews Device Daily Bulletin

FDA Grants 510(k) Clearance to Royal Philips’ Wearable Psoriasis Treatment Device

July 18, 2017

Royal Philips secured 510(k) clearance for its BlueControl light therapy device from the FDA, the company announced.

The wearable device, aimed at treating mild psoriasis, is a Class II, home-use prescription device. It obtained CE Mark approval in 2015 and has been rolled out in select European countries including the U.K. and Germany.

The company hopes to launch the device in the U.S. market in early 2018, in collaboration with dermatologists and patient support groups.

View today's stories