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)

Waterlase Laser System Family

K-Number: K190319 · 2019-10-10

ApplicantBiolase, Inc.
Decision Date2019-10-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Waterlase Laser System Family is the device name listed in this FDA 510(k) record. The listed applicant is Biolase, Inc.. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K190319. 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 Waterlase Laser System Family?

Waterlase Laser System Family is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Biolase, Inc.. The 510(k) number is K190319.

When did Waterlase Laser System Family receive FDA 510(k) clearance?

Waterlase Laser System Family received FDA 510(k) clearance on 2019-10-10, under 510(k) number K190319.

Who is the listed applicant for Waterlase Laser System Family?

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 Waterlase Laser System Family?

The FDA product code for Waterlase Laser System Family 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 980K172771Epic 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.

↑