Epic 980
K-Number: K193486 · 2020-03-16
ApplicantBiolase, Inc.
Decision Date2020-03-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Epic 980 is a medical device manufactured by Biolase, Inc.. It received FDA 510(k) clearance on 2020-03-16 under approval number K193486. 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 980?
Epic 980 is a medical device that received FDA 510(k) clearance on 2020-03-16. It is manufactured by Biolase, Inc.. The 510(k) number is K193486.
When was Epic 980 approved by the FDA?
Epic 980 received FDA 510(k) clearance on 2020-03-16, under approval number K193486.
What company makes Epic 980?
Epic 980 is manufactured by Biolase, Inc..
What is the FDA product code for Epic 980?
The FDA product code for Epic 980 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.