Laser Treatment System, Model: NYX and Grace
K-Number: K210033 · 2021-02-26
Decision Date2021-02-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Laser Treatment System, Model: NYX and Grace is a medical device manufactured by Canadian Pioneer Medical Technology Corporation. It received FDA 510(k) clearance on 2021-02-26 under approval 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.
Frequently Asked Questions
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. It is manufactured by Canadian Pioneer Medical Technology Corporation. The 510(k) number is K210033.
When was Laser Treatment System, Model: NYX and Grace approved by the FDA?
Laser Treatment System, Model: NYX and Grace received FDA 510(k) clearance on 2021-02-26, under approval number K210033.
What company makes Laser Treatment System, Model: NYX and Grace?
Laser Treatment System, Model: NYX and Grace is manufactured by Canadian Pioneer Medical Technology Corporation.
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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Official Source
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