FDA 510(k)

Project E Beauty LED 光疗面膜（型号：PE730）

K号: K214101 · 2022-03-23

决定日期2022-03-23

产品代码OHS

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决定实质等同

器械摘要

Project E Beauty LED Light Therapy Mask (Model: PE730) is the device name listed in this FDA 510(k) record. The listed applicant is Duplex International Trading Limited. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K214101. 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 Project E Beauty LED Light Therapy Mask (Model: PE730)?

Project E Beauty LED Light Therapy Mask (Model: PE730) is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Duplex International Trading Limited. The 510(k) number is K214101.

When did Project E Beauty LED Light Therapy Mask (Model: PE730) receive FDA 510(k) clearance?

Project E Beauty LED Light Therapy Mask (Model: PE730) received FDA 510(k) clearance on 2022-03-23, under 510(k) number K214101.

Who is the listed applicant for Project E Beauty LED Light Therapy Mask (Model: PE730)?

FDA 510(k)记录显示Duplex International Trading Limited为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Project E Beauty LED Light Therapy Mask (Model: PE730)?

The FDA product code for Project E Beauty LED Light Therapy Mask (Model: PE730) is OHS.

列明Duplex International Trading Limited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。

K261496LED光疗面罩（PE748，PE749，PE756）

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 Limited K261482LightStim抗皱仪（1984年）；LightStim祛痘仪（2038年）Led Intellectual Properties, LLC

官方来源

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