LUCERNA Dental Laser
K-Number: K161185 · 2016-09-26
ApplicantViax Dental Lab
Decision Date2016-09-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LUCERNA Dental Laser is a medical device manufactured by Viax Dental Lab. It received FDA 510(k) clearance on 2016-09-26 under approval 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.
Frequently Asked Questions
What is the LUCERNA Dental Laser?
LUCERNA Dental Laser is a medical device that received FDA 510(k) clearance on 2016-09-26. It is manufactured by Viax Dental Lab. The 510(k) number is K161185.
When was LUCERNA Dental Laser approved by the FDA?
LUCERNA Dental Laser received FDA 510(k) clearance on 2016-09-26, under approval number K161185.
What company makes LUCERNA Dental Laser?
LUCERNA Dental Laser is manufactured by Viax Dental Lab.
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.