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FDA 510(k)

WATERLASE

K-Number: K031140 · 2004-07-07

ApplicantBiolase Technology, Inc.
Decision Date2004-07-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WATERLASE is the device name listed in this FDA 510(k) record. The listed applicant is Biolase Technology, Inc.. It received FDA 510(k) clearance on 2004-07-07 under 510(k) number K031140. 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?

WATERLASE is a medical device that received FDA 510(k) clearance on 2004-07-07. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K031140.

When did WATERLASE receive FDA 510(k) clearance?

WATERLASE received FDA 510(k) clearance on 2004-07-07, under 510(k) number K031140.

Who is the listed applicant for WATERLASE?

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

What is the FDA product code for WATERLASE?

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

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Other records listing Biolase Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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