FDA 510(k)

超頻脈波CO2外科及美容雷射系列、輸送設備及配件

K 號：K220467 · 2022-05-18

決定日期2022-05-18

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

The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2022-05-18 under 510(k) number K220467. 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 The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories?

The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2022-05-18. The listed applicant is Lumenis Be, Ltd.. The 510(k) number is K220467.

When did The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories receive FDA 510(k) clearance?

The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories received FDA 510(k) clearance on 2022-05-18, under 510(k) number K220467.

Who is the listed applicant for The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories?

FDA 510(k) 記錄將 Lumenis Be, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories?

The FDA product code for The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.