SIROLaser Blue
K-Number: K180044 · 2018-03-08
ApplicantDentsply Sirona
Decision Date2018-03-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SIROLaser Blue is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2018-03-08 under approval number K180044. 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 SIROLaser Blue?
SIROLaser Blue is a medical device that received FDA 510(k) clearance on 2018-03-08. It is manufactured by Dentsply Sirona. The 510(k) number is K180044.
When was SIROLaser Blue approved by the FDA?
SIROLaser Blue received FDA 510(k) clearance on 2018-03-08, under approval number K180044.
What company makes SIROLaser Blue?
SIROLaser Blue is manufactured by Dentsply Sirona.
What is the FDA product code for SIROLaser Blue?
The FDA product code for SIROLaser Blue 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.