FDA 510(k)

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares

N.º K: K211722 · 2022-02-25

SolicitanteCanadian Pioneer Medical Technology Corporation

Fecha de decisión2022-02-25

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares 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 2022-02-25 under 510(k) number K211722. 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 , models Nyx plus, Grace plus, Nemesis, Ares?

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Canadian Pioneer Medical Technology Corporation. The 510(k) number is K211722.

When did Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares receive FDA 510(k) clearance?

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares received FDA 510(k) clearance on 2022-02-25, under 510(k) number K211722.

Who is the listed applicant for Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares?

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 , models Nyx plus, Grace plus, Nemesis, Ares?

The FDA product code for Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares is GEX. This falls under the Gastroenterology category.

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

K212793Laser Treatment System, Model: Hera, Armo K210033Laser Treatment System, Model: NYX and Grace

Dispositivos relacionados (Código: GEX)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.