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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 a medical device manufactured by Canadian Pioneer Medical Technology Corporation (Cpmt Laser). It received FDA 510(k) clearance on 2022-11-17 under approval 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. It is manufactured by Canadian Pioneer Medical Technology Corporation (Cpmt Laser). The 510(k) number is K222673.

When was Alexandrite and Nd:YAG Laser models CANLASE and TORLASE approved by the FDA?

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

What company makes Alexandrite and Nd:YAG Laser models CANLASE and TORLASE?

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE is manufactured by Canadian Pioneer Medical Technology Corporation (Cpmt Laser).

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

NCT06960447 Nd:YAG vs Alexandrite Laser Treatment in Hidradenitis Suppurativa NOT_YET_RECRUITING

Other Devices by Canadian Pioneer Medical Technology Corporation (Cpmt Laser)

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

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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.

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