Waterlase iPLus
K-Number: K210183 · 2022-04-21
ApplicantBiolase, Inc.
Decision Date2022-04-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Waterlase iPLus is a medical device manufactured by Biolase, Inc.. It received FDA 510(k) clearance on 2022-04-21 under approval number K210183. 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 iPLus?
Waterlase iPLus is a medical device that received FDA 510(k) clearance on 2022-04-21. It is manufactured by Biolase, Inc.. The 510(k) number is K210183.
When was Waterlase iPLus approved by the FDA?
Waterlase iPLus received FDA 510(k) clearance on 2022-04-21, under approval number K210183.
What company makes Waterlase iPLus?
Waterlase iPLus is manufactured by Biolase, Inc..
What is the FDA product code for Waterlase iPLus?
The FDA product code for Waterlase iPLus 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.