FDA 510(k)

LUCERNA Dental Laser

Número K: K161185 · 2016-09-26

Data da decisão2016-09-26

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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