FDA 510(k)

Fotona XPulse 激光系統家族（XPulse 1064 nm、XPulse 810 nm、XPulse 980 nm）

K 號：K221712 · 2022-10-12

決定日期2022-10-12

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

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K221712. 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 Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)?

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Fotona D.O.O.. The 510(k) number is K221712.

When did Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) receive FDA 510(k) clearance?

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) received FDA 510(k) clearance on 2022-10-12, under 510(k) number K221712.

Who is the listed applicant for Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)?

FDA 510(k) 記錄將 Fotona D.O.O. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)?

The FDA product code for Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) is GEX. This falls under the Gastroenterology category.