FDA 510(k)

LED硅胶面罩（型号：LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200）

K号: K233114 · 2024-01-12

决定日期2024-01-12

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

LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Idea Light Limited. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233114. 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 LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)?

LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Shenzhen Idea Light Limited. The 510(k) number is K233114.

When did LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) receive FDA 510(k) clearance?

LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233114.

Who is the listed applicant for LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)?

The FDA 510(k) record lists Shenzhen Idea Light Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)?

The FDA product code for LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) is OHS.

列明Shenzhen Idea Light 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。

K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。