FDA 510(k)

外科綠色雷射系統

K 號：K202828 · 2021-06-04

申請人Realton (Suzhou) Medical Technology Co., Ltd.

決定日期2021-06-04

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

Surgical Green Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Realton (Suzhou) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K202828. 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 Surgical Green Laser System?

Surgical Green Laser System is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Realton (Suzhou) Medical Technology Co., Ltd.. The 510(k) number is K202828.

When did Surgical Green Laser System receive FDA 510(k) clearance?

Surgical Green Laser System received FDA 510(k) clearance on 2021-06-04, under 510(k) number K202828.

Who is the listed applicant for Surgical Green Laser System?

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

What is the FDA product code for Surgical Green Laser System?

The FDA product code for Surgical Green Laser System is GEX. This falls under the Gastroenterology category.

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