FDA 510(k)

ルメニスファミリーのホルミウム手術レーザーおよびデリバリーデバイスおよびアクセサリー

K番号: K170121 · 2017-05-22

決定日2017-05-22

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

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.

よくある質問

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.