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FDA 510(k)

强脉冲光设备，型号：DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G。

K号: K231613 · 2023-07-31

申请人Zhuzhou Goldenhot Medical Technology Co., Ltd.
决定日期2023-07-31
产品代码OHT
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

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. is the device name listed in this FDA 510(k) record. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K231613. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.?

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. The 510(k) number is K231613.

When did Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. receive FDA 510(k) clearance?

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. received FDA 510(k) clearance on 2023-07-31, under 510(k) number K231613.

Who is the listed applicant for Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.?

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

What is the FDA product code for Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.?

The FDA product code for Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. is OHT.

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

列明Zhuzhou Goldenhot Medical Technology 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。

K243085IPL脱毛仪（DE03A-W，DE03A-P，DE03A-V，DE03A-G，DE03B-W，DE03B-P，DE03B-V，DE03B-G）K240109医用电子体温计（FC01, FC02）

相关器械（代码：OHT）

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。

K261977Braun Aura 9（6042）Cyden LimitedK262524蓝宝石冷却IPL脱毛设备（冰2.0，冰2.1，冰2.2，冰2.0B，冰2.1B，冰2.2B）ONE BEAUTY Technology Co., Ltd.K261705脱毛设备（R3C16-G Pro，R3C16-V Pro）Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325冰冷却IPL脱毛设备（UI06S PR，UI06S PN，UI06S WH，UI06S PRU，UI06S PNU，UI06S WHU）Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL脱毛仪（FL-B505AG，FL-B505AP，FL-B505AM，FL-B507AG，FL-B507AP，FL-B507AM，FL-B508AG，FL-B508AP，FL-B508AM，FL-B509AG，FL-B509AP，FL-B509AM，FL-B510G，FL-B510P，FL-B510M，FL-B511G，FL-B511P，FL-B511M，FL-B512AG，FL-B512AP，FL-B512AM，FL-B513AG，FL-B513AP，FL-B513AM）Shenzhen Xiazhifeng Electronic Co., Ltd.K260742冰冷却IPL脱毛设备（UI20S DB，UI20S RE，UI20S PW，UI20S GP，UI20S GR，UI20S BK）Shenzhen Ulike Smart Electronics Co., Ltd.

官方来源

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