FDA 510(k)

雷射治療設備

K 號：K202980 · 2020-11-19

申請人Shenzhen Leaflife Technology Co., Ltd.

決定日期2020-11-19

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

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