Waterlase Laser System Family
K-Number: K190319 · 2019-10-10
ApplicantBiolase, Inc.
Decision Date2019-10-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Waterlase Laser System Family is a medical device manufactured by Biolase, Inc.. It received FDA 510(k) clearance on 2019-10-10 under approval number K190319. 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 Laser System Family?
Waterlase Laser System Family is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Biolase, Inc.. The 510(k) number is K190319.
When was Waterlase Laser System Family approved by the FDA?
Waterlase Laser System Family received FDA 510(k) clearance on 2019-10-10, under approval number K190319.
What company makes Waterlase Laser System Family?
Waterlase Laser System Family is manufactured by Biolase, Inc..
What is the FDA product code for Waterlase Laser System Family?
The FDA product code for Waterlase Laser System Family 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.