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FDA 510(k)

EPIC 10

K-Number: K121286 · 2012-09-28

ApplicantBiolase Technology, Inc.
Decision Date2012-09-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPIC 10 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 2012-09-28 under 510(k) number K121286. 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 EPIC 10?

EPIC 10 is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K121286.

When did EPIC 10 receive FDA 510(k) clearance?

EPIC 10 received FDA 510(k) clearance on 2012-09-28, under 510(k) number K121286.

Who is the listed applicant for EPIC 10?

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 EPIC 10?

The FDA product code for EPIC 10 is GEX. This falls under the Gastroenterology category.

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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