Waterlase Express
K-Number: K161669 · 2016-07-28
ApplicantBiolase, Inc.
Decision Date2016-07-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Waterlase Express is a medical device manufactured by Biolase, Inc.. It received FDA 510(k) clearance on 2016-07-28 under approval number K161669. 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 Waterlase Express?
Waterlase Express is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Biolase, Inc.. The 510(k) number is K161669.
When was Waterlase Express approved by the FDA?
Waterlase Express received FDA 510(k) clearance on 2016-07-28, under approval number K161669.
What company makes Waterlase Express?
Waterlase Express is manufactured by Biolase, Inc..
What is the FDA product code for Waterlase Express?
The FDA product code for Waterlase Express 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.