美國雷射工坊Patriot 1系列雷射
K 號：K162334 · 2017-04-27
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器材摘要
U.S. Laser Worx Patriot 1 family of lasers is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Laser Worx. It received FDA 510(k) clearance on 2017-04-27 under 510(k) number K162334. 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 U.S. Laser Worx Patriot 1 family of lasers?
U.S. Laser Worx Patriot 1 family of lasers is a medical device that received FDA 510(k) clearance on 2017-04-27. The listed applicant is U.S. Laser Worx. The 510(k) number is K162334.
When did U.S. Laser Worx Patriot 1 family of lasers receive FDA 510(k) clearance?
U.S. Laser Worx Patriot 1 family of lasers received FDA 510(k) clearance on 2017-04-27, under 510(k) number K162334.
Who is the listed applicant for U.S. Laser Worx Patriot 1 family of lasers?
The FDA 510(k) record lists U.S. Laser Worx as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for U.S. Laser Worx Patriot 1 family of lasers?
The FDA product code for U.S. Laser Worx Patriot 1 family of lasers is GEX. This falls under the Gastroenterology category.
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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。
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官方來源
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