FDA 510(k)

Nobleen 长脉冲翠绿宝石 & Nd: YAG 激光系统

K号: K182663 · 2018-11-30

决定日期2018-11-30

产品代码GEX

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决定实质等同

器械摘要

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Finemec Co., Ltd.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K182663. 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.

常见问题

What is the Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System?

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Finemec Co., Ltd.. The 510(k) number is K182663.

When did Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System receive FDA 510(k) clearance?

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System received FDA 510(k) clearance on 2018-11-30, under 510(k) number K182663.

Who is the listed applicant for Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System?

The FDA 510(k) record lists Finemec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System?

The FDA product code for Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is GEX. This falls under the Gastroenterology category.

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Nobleen 长脉冲翠绿宝石 & Nd: YAG 激光系统

器械摘要

常见问题

相关临床试验

相关器械（代码：GEX）

官方来源