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FDA 510(k)

B.Light Clear Evo 和 B.Light Restore Evo

K号: K223919 · 2023-09-23

申请人Bemer Int AG
决定日期2023-09-23
产品代码OHS
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

B.Light Clear Evo and B.Light Restore Evo is the device name listed in this FDA 510(k) record. The listed applicant is Bemer Int AG. It received FDA 510(k) clearance on 2023-09-23 under 510(k) number K223919. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the B.Light Clear Evo and B.Light Restore Evo?

B.Light Clear Evo and B.Light Restore Evo is a medical device that received FDA 510(k) clearance on 2023-09-23. The listed applicant is Bemer Int AG. The 510(k) number is K223919.

When did B.Light Clear Evo and B.Light Restore Evo receive FDA 510(k) clearance?

B.Light Clear Evo and B.Light Restore Evo received FDA 510(k) clearance on 2023-09-23, under 510(k) number K223919.

Who is the listed applicant for B.Light Clear Evo and B.Light Restore Evo?

The FDA 510(k) record lists Bemer Int AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B.Light Clear Evo and B.Light Restore Evo?

The FDA product code for B.Light Clear Evo and B.Light Restore Evo is OHS.

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Bemer Int AG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。

K231368Bemer 疗法系统 EvoK210174BEMER 疗法系统，BEMER Classic Set, BEMER Pro-SetK151834BEMER Classic Set, BEMER Pro-Set

相关器械（代码：OHS）

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。

K260767面部美容设备（面部面膜LED美容设备A-901；面部LED & EMS美容设备A-902；面部面膜LED & EMS美容设备A-907）Kam Yuen Plastic Products , Ltd.K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED光疗面罩（M01、M02、M03、M05、M06、M07、M08）Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED光疗面罩（JML1，JML1+JML2）；LED光疗面罩（JML3，JML3+JML4）；LED光疗面罩（JML5，JML5+JML7）；LED光疗面罩（JML6，JML6+JML8）；LED光疗面罩（JML9，JML9+JML10）Shenzhen Qianyu Technology Co., Ltd.K261496LED光疗面罩（PE748，PE749，PE756）Duplex International Trading LimitedK261482LightStim抗皱仪（1984年）；LightStim祛痘仪（2038年）Led Intellectual Properties, LLC

官方来源

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