Laser Treatment System, Model: Hera, Armo
K-Number: K212793 · 2021-10-25
Decision Date2021-10-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Laser Treatment System, Model: Hera, Armo is a medical device manufactured by Canadian Pioneer Medical Technology Corporation. It received FDA 510(k) clearance on 2021-10-25 under approval 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.
Frequently Asked Questions
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. It is manufactured by Canadian Pioneer Medical Technology Corporation. The 510(k) number is K212793.
When was Laser Treatment System, Model: Hera, Armo approved by the FDA?
Laser Treatment System, Model: Hera, Armo received FDA 510(k) clearance on 2021-10-25, under approval number K212793.
What company makes Laser Treatment System, Model: Hera, Armo?
Laser Treatment System, Model: Hera, Armo is manufactured by Canadian Pioneer Medical Technology Corporation.
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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Official Source
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