FDA 510(k)

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K番号: K161185 · 2016-09-26

決定日2016-09-26

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

LUCERNA Dental Laser is the device name listed in this FDA 510(k) record. The listed applicant is Viax Dental Lab. It received FDA 510(k) clearance on 2016-09-26 under 510(k) number K161185. 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 LUCERNA Dental Laser?

LUCERNA Dental Laser is a medical device that received FDA 510(k) clearance on 2016-09-26. The listed applicant is Viax Dental Lab. The 510(k) number is K161185.

When did LUCERNA Dental Laser receive FDA 510(k) clearance?

LUCERNA Dental Laser received FDA 510(k) clearance on 2016-09-26, under 510(k) number K161185.

Who is the listed applicant for LUCERNA Dental Laser?

The FDA 510(k) record lists Viax Dental Lab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUCERNA Dental Laser?

The FDA product code for LUCERNA Dental Laser is GEX. This falls under the Gastroenterology category.

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医療機器の概要

よくある質問

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