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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biolase, Inc.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) 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. The listed applicant is Biolase, Inc.. The 510(k) number is K161669.

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

Waterlase Express received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161669.

Who is the listed applicant for Waterlase Express?

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 Express?

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

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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