FDA 510(k)

皮膚科用炭酸ガスレーザーシステム

K番号: K202250 · 2020-11-25

申請者Zhuolu Jontelaser Manufacturing Technology Co., Ltd.

決定日2020-11-25

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてZhuolu Jontelaser Manufacturing Technology Co., Ltd.を記載するその他の記録

K202257皮膚科用二重線激光システム

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