FDA 510(k)

LED治疗设备（平面LED/平面LED mini）

K号: K220103 · 2022-04-12

申请人Shenzhen Leaflife Technology Co., Ltd.

决定日期2022-04-12

产品代码GEX

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决定实质等同

器械摘要

LED Therapy Device (Planar LED/Planar LED mini) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K220103. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the LED Therapy Device (Planar LED/Planar LED mini)?

LED Therapy Device (Planar LED/Planar LED mini) is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K220103.

When did LED Therapy Device (Planar LED/Planar LED mini) receive FDA 510(k) clearance?

LED Therapy Device (Planar LED/Planar LED mini) received FDA 510(k) clearance on 2022-04-12, under 510(k) number K220103.

Who is the listed applicant for LED Therapy Device (Planar LED/Planar LED mini)?

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

What is the FDA product code for LED Therapy Device (Planar LED/Planar LED mini)?

The FDA product code for LED Therapy Device (Planar LED/Planar LED mini) is GEX. This falls under the Gastroenterology category.

列明Shenzhen Leaflife Technology 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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