510(k) K242977

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) by Xuzhou Kernel Medical Equipment Co., Ltd. — Product Code FTC

K242977 is an FDA 510(k) premarket notification submitted by Xuzhou Kernel Medical Equipment Co., Ltd. for the device "308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)". The FDA issued a decision of Substantially Equivalent on February 6, 2025. 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.