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FDA 510(k)

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）

K号: K242908 · 2024-12-19

申请人Shanghai Sigma High-Tech Co., Ltd.
决定日期2024-12-19
产品代码FTC
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sigma High-Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242908. 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 UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)?

UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Shanghai Sigma High-Tech Co., Ltd.. The 510(k) number is K242908.

When did UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) receive FDA 510(k) clearance?

UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242908.

Who is the listed applicant for UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)?

The FDA 510(k) record lists Shanghai Sigma High-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)?

The FDA product code for UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) is FTC.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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, LLCK250425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.K242977308nm准分子光疗设备（CN-308E，KN-4003B3，KN-4003B4，KN-5000C KN-5000D，KN-5000H，KN-5000K）Xuzhou Kernel Medical Equipment 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。

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