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FDA 510(k)

窄带紫外线光疗灯（型号：HB-UPLL-01，HB-UPLL-02）

K号: K223882 · 2023-03-27

申请人Shenzhen Honpal Optoelectronic Technology Co., Ltd.
决定日期2023-03-27
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

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Honpal Optoelectronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-27 under 510(k) number K223882. 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 Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is a medical device that received FDA 510(k) clearance on 2023-03-27. The listed applicant is Shenzhen Honpal Optoelectronic Technology Co., Ltd.. The 510(k) number is K223882.

When did Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) receive FDA 510(k) clearance?

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) received FDA 510(k) clearance on 2023-03-27, under 510(k) number K223882.

Who is the listed applicant for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

The FDA 510(k) record lists Shenzhen Honpal Optoelectronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

The FDA product code for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) 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.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.

官方来源

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