Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Epic 980

K-Number: K192430 · 2019-12-04

ApplicantBiolase, Inc.
Decision Date2019-12-04
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 2019-12-04 under 510(k) number K192430. 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 2019-12-04. The listed applicant is Biolase, Inc.. The 510(k) number is K192430.

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

Epic 980 received FDA 510(k) clearance on 2019-12-04, under 510(k) number K192430.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210183Waterlase iPLusK213428EdgeProK193486Epic 980K190319Waterlase Laser System FamilyK172771Epic Pro 940K163128Epic Pro

View all 8 devices →

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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.

↑