SIROLaser Advance+
K-Number: K170500 · 2017-05-16
ApplicantDentsply Sirona
Decision Date2017-05-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SIROLaser Advance+ is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2017-05-16 under approval number K170500. 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 Advance+?
SIROLaser Advance+ is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by Dentsply Sirona. The 510(k) number is K170500.
When was SIROLaser Advance+ approved by the FDA?
SIROLaser Advance+ received FDA 510(k) clearance on 2017-05-16, under approval number K170500.
What company makes SIROLaser Advance+?
SIROLaser Advance+ is manufactured by Dentsply Sirona.
What is the FDA product code for SIROLaser Advance+?
The FDA product code for SIROLaser Advance+ 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.