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FDA 510(k)

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE

K-Number: K222673 · 2022-11-17

ApplicantCanadian Pioneer Medical Technology Corporation (Cpmt Laser)
Decision Date2022-11-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE 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 2022-11-17 under 510(k) number K222673. 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 Alexandrite and Nd:YAG Laser models CANLASE and TORLASE?

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Canadian Pioneer Medical Technology Corporation (Cpmt Laser). The 510(k) number is K222673.

When did Alexandrite and Nd:YAG Laser models CANLASE and TORLASE receive FDA 510(k) clearance?

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE received FDA 510(k) clearance on 2022-11-17, under 510(k) number K222673.

Who is the listed applicant for Alexandrite and Nd:YAG Laser models CANLASE and TORLASE?

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 Alexandrite and Nd:YAG Laser models CANLASE and TORLASE?

The FDA product code for Alexandrite and Nd:YAG Laser models CANLASE and TORLASE is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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.

NCT06960447Nd:YAG vs Alexandrite Laser Treatment in Hidradenitis SuppurativaNOT_YET_RECRUITING

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.

K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS

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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