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FDA 510(k)

光疗系统（M500，L6）

K号: K251042 · 2025-06-06

申请人Guangzhou Ahead Intelligent Technology Co., Ltd.
决定日期2025-06-06
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

Light Therapy System (M500, L6) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Ahead Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K251042. 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 Light Therapy System (M500, L6)?

Light Therapy System (M500, L6) is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Guangzhou Ahead Intelligent Technology Co., Ltd.. The 510(k) number is K251042.

When did Light Therapy System (M500, L6) receive FDA 510(k) clearance?

Light Therapy System (M500, L6) received FDA 510(k) clearance on 2025-06-06, under 510(k) number K251042.

Who is the listed applicant for Light Therapy System (M500, L6)?

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

What is the FDA product code for Light Therapy System (M500, L6)?

The FDA product code for Light Therapy System (M500, L6) is OHS.

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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。

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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

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