FDA 510(k)

ProFlex 激光纖維

K 號：K180140 · 2018-04-20

決定日期2018-04-20

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

ProFlex Laser Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Innovaquartz, LLC. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180140. 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 ProFlex Laser Fibers?

ProFlex Laser Fibers is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Innovaquartz, LLC. The 510(k) number is K180140.

When did ProFlex Laser Fibers receive FDA 510(k) clearance?

ProFlex Laser Fibers received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180140.

Who is the listed applicant for ProFlex Laser Fibers?

The FDA 510(k) record lists Innovaquartz, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProFlex Laser Fibers?

The FDA product code for ProFlex Laser Fibers is GEX. This falls under the Gastroenterology category.

其他以 Innovaquartz, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K233157VaporMAX LDD；MOJo LDD；MegaJOULE LDD K203799ProFlex 二氧化碳激光纖維

相關器械（代碼：GEX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro 系列Fotona D.O.O.K241973SmartIPL_NI 系統Lumenis Be, Ltd.K261047牙科二極雷射設備（雷射筆）Guilin Kevin Peter Technology Co., Ltd.K261817二極雷射治療系統（PZ-BDT67-01，PZ-BDT67-02）Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED治療設備（QLXY-01）Beijing Nubway S&T Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。