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FDA 510(k)

WATERLASE IPLUS ALL TISSUE LASER

K-Number: K122368 · 2013-05-02

ApplicantBiolase Technology, Inc.
Decision Date2013-05-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WATERLASE IPLUS ALL TISSUE LASER 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 2013-05-02 under 510(k) number K122368. 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 ALL TISSUE LASER?

WATERLASE IPLUS ALL TISSUE LASER is a medical device that received FDA 510(k) clearance on 2013-05-02. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K122368.

When did WATERLASE IPLUS ALL TISSUE LASER receive FDA 510(k) clearance?

WATERLASE IPLUS ALL TISSUE LASER received FDA 510(k) clearance on 2013-05-02, under 510(k) number K122368.

Who is the listed applicant for WATERLASE IPLUS ALL TISSUE LASER?

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 IPLUS ALL TISSUE LASER?

The FDA product code for WATERLASE IPLUS ALL TISSUE LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Biolase Technology, Inc. as applicant

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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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