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)

UltraLase Flexible CO2 Laser Waveguide

K-Number: K211761 · 2021-07-30

ApplicantW & R Investments, LLC Dba Laser Engineering
Decision Date2021-07-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraLase Flexible CO2 Laser Waveguide is the device name listed in this FDA 510(k) record. The listed applicant is W & R Investments, LLC Dba Laser Engineering. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K211761. 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 UltraLase Flexible CO2 Laser Waveguide?

UltraLase Flexible CO2 Laser Waveguide is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is W & R Investments, LLC Dba Laser Engineering. The 510(k) number is K211761.

When did UltraLase Flexible CO2 Laser Waveguide receive FDA 510(k) clearance?

UltraLase Flexible CO2 Laser Waveguide received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211761.

Who is the listed applicant for UltraLase Flexible CO2 Laser Waveguide?

The FDA 510(k) record lists W & R Investments, LLC Dba Laser Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraLase Flexible CO2 Laser Waveguide?

The FDA product code for UltraLase Flexible CO2 Laser Waveguide is GEX. This falls under the Gastroenterology category.

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.

↑