FDA 510(k)

激光治疗设备

K号: K202980 · 2020-11-19

申请人Shenzhen Leaflife Technology Co., Ltd.

决定日期2020-11-19

产品代码GEX

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

Laser Therapy Device 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 2020-11-19 under 510(k) number K202980. 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 Laser Therapy Device?

Laser Therapy Device is a medical device that received FDA 510(k) clearance on 2020-11-19. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K202980.

When did Laser Therapy Device receive FDA 510(k) clearance?

Laser Therapy Device received FDA 510(k) clearance on 2020-11-19, under 510(k) number K202980.

Who is the listed applicant for Laser Therapy Device?

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 Laser Therapy Device?

The FDA product code for Laser Therapy Device 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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官方来源

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