FDA 510(k)

皮膚科二氧化碳激光系統

K 號：K202250 · 2020-11-25

申請人Zhuolu Jontelaser Manufacturing Technology Co., Ltd.

決定日期2020-11-25

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

Dermatological Carbon Dioxide Laser Systems is the device name listed in this FDA 510(k) record. The listed applicant is Zhuolu Jontelaser Manufacturing Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K202250. 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 Dermatological Carbon Dioxide Laser Systems?

Dermatological Carbon Dioxide Laser Systems is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Zhuolu Jontelaser Manufacturing Technology Co., Ltd.. The 510(k) number is K202250.

When did Dermatological Carbon Dioxide Laser Systems receive FDA 510(k) clearance?

Dermatological Carbon Dioxide Laser Systems received FDA 510(k) clearance on 2020-11-25, under 510(k) number K202250.

Who is the listed applicant for Dermatological Carbon Dioxide Laser Systems?

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

What is the FDA product code for Dermatological Carbon Dioxide Laser Systems?

The FDA product code for Dermatological Carbon Dioxide Laser Systems is GEX. This falls under the Gastroenterology category.

其他以 Zhuolu Jontelaser Manufacturing Technology Co., Ltd. 為申請人之記錄

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