FDA 510(k)

HIGHERDOSE 红外光和红光面罩（MK66-L）

K号: K241933 · 2024-09-27

申请人Shenzhen Kaiyan Medical Equipment Co., Ltd.

决定日期2024-09-27

产品代码OHS

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决定实质等同

器械摘要

HIGHERDOSE Red and Infrared Light Mask (MK66-L) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K241933. 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 HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

HIGHERDOSE Red and Infrared Light Mask (MK66-L) is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K241933.

When did HIGHERDOSE Red and Infrared Light Mask (MK66-L) receive FDA 510(k) clearance?

HIGHERDOSE Red and Infrared Light Mask (MK66-L) received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241933.

Who is the listed applicant for HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

FDA 510(k)记录将深圳凯研医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

The FDA product code for HIGHERDOSE Red and Infrared Light Mask (MK66-L) is OHS.

列明Shenzhen Kaiyan Medical Equipment Co., Ltd.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。

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查看所有 24 个设备 →

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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