FDA 510(k)

Laser Treatment System, Model: NYX and Grace

N.º K: K210033 · 2021-02-26

SolicitanteCanadian Pioneer Medical Technology Corporation

Fecha de decisión2021-02-26

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Laser Treatment System, Model: NYX and Grace is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Pioneer Medical Technology Corporation. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K210033. 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.

Preguntas frecuentes

What is the Laser Treatment System, Model: NYX and Grace?

Laser Treatment System, Model: NYX and Grace is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Canadian Pioneer Medical Technology Corporation. The 510(k) number is K210033.

When did Laser Treatment System, Model: NYX and Grace receive FDA 510(k) clearance?

Laser Treatment System, Model: NYX and Grace received FDA 510(k) clearance on 2021-02-26, under 510(k) number K210033.

Who is the listed applicant for Laser Treatment System, Model: NYX and Grace?

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

What is the FDA product code for Laser Treatment System, Model: NYX and Grace?

The FDA product code for Laser Treatment System, Model: NYX and Grace is GEX. This falls under the Gastroenterology category.

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Otros registros que enlistan a Canadian Pioneer Medical Technology Corporation como solicitante

K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares K212793Laser Treatment System, Model: Hera, Armo

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Fuente oficial

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