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FDA 510(k)

Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS

K-Number: K222915 · 2022-11-15

ApplicantCanadian Pioneer Medical Technology Corporation (Cpmt Laser)
Decision Date2022-11-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Pioneer Medical Technology Corporation (Cpmt Laser). It received FDA 510(k) clearance on 2022-11-15 under 510(k) number K222915. 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 Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS?

Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Canadian Pioneer Medical Technology Corporation (Cpmt Laser). The 510(k) number is K222915.

When did Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS receive FDA 510(k) clearance?

Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS received FDA 510(k) clearance on 2022-11-15, under 510(k) number K222915.

Who is the listed applicant for Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS?

The FDA 510(k) record lists Canadian Pioneer Medical Technology Corporation (Cpmt Laser) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS?

The FDA product code for Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS is GEX. This falls under the Gastroenterology category.

Other records listing Canadian Pioneer Medical Technology Corporation (Cpmt Laser) 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.

K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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