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FDA 510(k)

TWILITE, TWILITE WHITE

K-Number: K003385 · 2001-01-25

ApplicantBiolase Technology, Inc.
Decision Date2001-01-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TWILITE, TWILITE WHITE 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 2001-01-25 under 510(k) number K003385. 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 TWILITE, TWILITE WHITE?

TWILITE, TWILITE WHITE is a medical device that received FDA 510(k) clearance on 2001-01-25. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K003385.

When did TWILITE, TWILITE WHITE receive FDA 510(k) clearance?

TWILITE, TWILITE WHITE received FDA 510(k) clearance on 2001-01-25, under 510(k) number K003385.

Who is the listed applicant for TWILITE, TWILITE WHITE?

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 TWILITE, TWILITE WHITE?

The FDA product code for TWILITE, TWILITE WHITE 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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