FDA 510(k)

AcuPulse CO2 激光系統，輸送設備和附件

K 號：K212703 · 2021-10-19

決定日期2021-10-19

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

AcuPulse CO2 Laser System, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K212703. 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 AcuPulse CO2 Laser System, Delivery Devices and Accessories?

AcuPulse CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Lumenis, Ltd.. The 510(k) number is K212703.

When did AcuPulse CO2 Laser System, Delivery Devices and Accessories receive FDA 510(k) clearance?

AcuPulse CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2021-10-19, under 510(k) number K212703.

Who is the listed applicant for AcuPulse CO2 Laser System, Delivery Devices and Accessories?

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

What is the FDA product code for AcuPulse CO2 Laser System, Delivery Devices and Accessories?

The FDA product code for AcuPulse CO2 Laser System, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

其他以 Lumenis, Ltd. 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。

K203544超頻術美激光系統，輸送設備及配件 K202428AcuPulse W CO2 激光系統，輸送設備和附件 K201663AcuPulse W CO2 激光系統，輸送設備和附件 K193500Stellar M22 高強度脈衝光（IPL）及雷射系統 K180597AcuPulse (以前稱為 AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO K170179LightSheer Desire；LightSheer Desire Light；LightSheer Duet；LightSheer Infinity

查看所有 10 項裝置 →

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。