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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biolase, Inc.. It received FDA 510(k) clearance on 2022-04-21 under 510(k) 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. The listed applicant is Biolase, Inc.. The 510(k) number is K210183.

When did Waterlase iPLus receive FDA 510(k) clearance?

Waterlase iPLus received FDA 510(k) clearance on 2022-04-21, under 510(k) number K210183.

Who is the listed applicant for Waterlase iPLus?

The FDA 510(k) record lists Biolase, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Waterlase iPLus?

The FDA product code for Waterlase iPLus is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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NCT05555043Comparison of Clinical Outcomes Between GentleWave® and Biolase®COMPLETED

Other records listing Biolase, Inc. as applicant

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Related Devices (Code: GEX)

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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.

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