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FDA 510(k)

EZLASE 10W

K-Number: K083069 · 2008-11-13

ApplicantBiolase Technology, Inc.
Decision Date2008-11-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EZLASE 10W 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 2008-11-13 under 510(k) number K083069. 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 EZLASE 10W?

EZLASE 10W is a medical device that received FDA 510(k) clearance on 2008-11-13. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K083069.

When did EZLASE 10W receive FDA 510(k) clearance?

EZLASE 10W received FDA 510(k) clearance on 2008-11-13, under 510(k) number K083069.

Who is the listed applicant for EZLASE 10W?

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 EZLASE 10W?

The FDA product code for EZLASE 10W 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.

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