FDA 510(k)

外科绿色激光系统

K号: K202828 · 2021-06-04

申请人Realton (Suzhou) Medical Technology Co., Ltd.

决定日期2021-06-04

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

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.

常见问题

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.

列明Realton (Suzhou) Medical 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。

K202702FLARE 单次使用手术激光光纤 K202601一次性无菌医用激光光纤

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