FDA 510(k)

LUCERNA 牙科激光器

K号: K161185 · 2016-09-26

决定日期2016-09-26

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

官方来源

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LUCERNA 牙科激光器

器械摘要

常见问题

相关临床试验

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官方来源