510(k) K181805

UV Phototherapy by Xuzhou Kernel Medical Equipment Co., Ltd. — Product Code FTC

K181805 is an FDA 510(k) premarket notification submitted by Xuzhou Kernel Medical Equipment Co., Ltd. for the device "UV Phototherapy". The FDA issued a decision of Substantially Equivalent on January 11, 2019. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Xuzhou Kernel Medical Equipment Co., Ltd. has at least 7 other 510(k) clearances on record.