FDA 510(k)

LightStim Elipsa

K号: K212771 · 2022-01-26

决定日期2022-01-26

产品代码OHS

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决定实质等同

器械摘要

LightStim Elipsa is the device name listed in this FDA 510(k) record. The listed applicant is Led Intellectual Properties, LLC. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K212771. 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 LightStim Elipsa?

LightStim Elipsa is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Led Intellectual Properties, LLC. The 510(k) number is K212771.

When did LightStim Elipsa receive FDA 510(k) clearance?

LightStim Elipsa received FDA 510(k) clearance on 2022-01-26, under 510(k) number K212771.

Who is the listed applicant for LightStim Elipsa?

FDA 510(k)记录显示Led Intellectual Properties, LLC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 LightStim Elipsa?

The FDA product code for LightStim Elipsa is OHS.

列明Led Intellectual Properties, LLC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。

K261482LightStim抗皱仪（1984年）；LightStim祛痘仪（2038年）K153399LightStim专业LED床

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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