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FDA 510(k)

LASERSMILE

K-Number: K030539 · 2003-10-10

ApplicantBiolase Technology, Inc.
Decision Date2003-10-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSMILE 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 2003-10-10 under 510(k) number K030539. 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 LASERSMILE?

LASERSMILE is a medical device that received FDA 510(k) clearance on 2003-10-10. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K030539.

When did LASERSMILE receive FDA 510(k) clearance?

LASERSMILE received FDA 510(k) clearance on 2003-10-10, under 510(k) number K030539.

Who is the listed applicant for LASERSMILE?

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 LASERSMILE?

The FDA product code for LASERSMILE 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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