FDA 510(k)

Lumenis系列鐵激光外科激光器及傳遞設備和附件

K 號：K170121 · 2017-05-22

決定日期2017-05-22

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

Lumenis Family of Holmium Surgical Lasers and 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 2017-05-22 under 510(k) number K170121. 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 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories?

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2017-05-22. The listed applicant is Lumenis, Ltd.. The 510(k) number is K170121.

When did Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories receive FDA 510(k) clearance?

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories received FDA 510(k) clearance on 2017-05-22, under 510(k) number K170121.

Who is the listed applicant for Lumenis Family of Holmium Surgical Lasers and 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 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories?

The FDA product code for Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.