About This 510(k) Submission
K242977 is an FDA 510(k) clearance for the 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K), a Light, Ultraviolet, Dermatological (Class II — Special Controls, product code FTC), submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Xuzhou, CN). The FDA issued a Cleared decision on February 6, 2025, 133 days after receiving the submission on September 26, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.