FDA 510(k)

Laser Treatment System, Model: Hera, Armo

Número K: K212793 · 2021-10-25

RequerenteCanadian Pioneer Medical Technology Corporation

Data da decisão2021-10-25

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Laser Treatment System, Model: Hera, Armo 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 2021-10-25 under 510(k) number K212793. 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 Laser Treatment System, Model: Hera, Armo?

Laser Treatment System, Model: Hera, Armo is a medical device that received FDA 510(k) clearance on 2021-10-25. The listed applicant is Canadian Pioneer Medical Technology Corporation. The 510(k) number is K212793.

When did Laser Treatment System, Model: Hera, Armo receive FDA 510(k) clearance?

Laser Treatment System, Model: Hera, Armo received FDA 510(k) clearance on 2021-10-25, under 510(k) number K212793.

Who is the listed applicant for Laser Treatment System, Model: Hera, Armo?

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: Hera, Armo?

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

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