FDA 510(k)

308nm准分子光疗设备（CN-308E，KN-4003B3，KN-4003B4，KN-5000C KN-5000D，KN-5000H，KN-5000K）

K号: K242977 · 2025-02-06

申请人Xuzhou Kernel Medical Equipment Co., Ltd.

决定日期2025-02-06

产品代码FTC

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决定实质等同

器械摘要

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K242977. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)?

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K242977.

When did 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) receive FDA 510(k) clearance?

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) received FDA 510(k) clearance on 2025-02-06, under 510(k) number K242977.

Who is the listed applicant for 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)?

FDA 510(k)记录将徐州核芯医疗设备股份有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)?

The FDA product code for 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is FTC.

列明Xuzhou Kernel Medical Equipment Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261775紫外线光疗仪（KN-4001A，KN-4001B，KN-4001AB）K222751LED光疗设备，KN-7000L K200971308nm准分子系统 K200929Hair Growth System K190685Hair Growth System K181805紫外线光疗

查看所有 8 个设备 →

相关器械（代码：FTC）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254234光疗系统 (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite（RCW-KL1000）Radcliffe Watts, LLC K250425紫外线光疗设备APK Technology Co., Ltd.K244022308nm紫外线光疗系统（UV-K）；308nm紫外线光疗系统（UV-X）；308nm紫外线光疗系统（UV-Y）；308nm紫外线光疗系统（UV-Z）Boston Aesthetics, Inc.K242908紫外线光疗设备（A组：SQ308PCHFD，SQ308PCQFD，SQ308PCPFD，SQ308PCNFD，SQ308PCMFD）；紫外线光疗设备（B组：SQ308PHTFF，SQ308PHSFF，SQ308PHRFF，SQ308PHZFG，SQ308PPUFF，SQ308PPVFF，SQ308PPWFG）Shanghai Sigma High-Tech Co., Ltd.K233811DT 控制光疗设备Daavlin Distributing Co.

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。