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 Pro 940

K-Number: K172771 · 2017-11-29

ApplicantBiolase, Inc.
Decision Date2017-11-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Epic Pro 940 is the device name listed in this FDA 510(k) record. The listed applicant is Biolase, Inc.. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172771. 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 Pro 940?

Epic Pro 940 is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Biolase, Inc.. The 510(k) number is K172771.

When did Epic Pro 940 receive FDA 510(k) clearance?

Epic Pro 940 received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172771.

Who is the listed applicant for Epic Pro 940?

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 Pro 940?

The FDA product code for Epic Pro 940 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 980K192430Epic 980K190319Waterlase Laser System FamilyK163128Epic 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.

↑