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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biolase, Inc.. It received FDA 510(k) clearance on 2020-03-16 under 510(k) 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. The listed applicant is Biolase, Inc.. The 510(k) number is K193486.

When did Epic 980 receive FDA 510(k) clearance?

Epic 980 received FDA 510(k) clearance on 2020-03-16, under 510(k) number K193486.

Who is the listed applicant for Epic 980?

The FDA 510(k) record lists Biolase, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Epic 980?

The FDA product code for Epic 980 is GEX. This falls under the Gastroenterology category.

Other records listing Biolase, 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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