FDA 510(k)

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

Número K: K222915 · 2022-11-15

RequerenteCanadian Pioneer Medical Technology Corporation (Cpmt Laser)

Data da decisão2022-11-15

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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