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FDA 510(k)

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

K-Number: K211722 · 2022-02-25

ApplicantCanadian Pioneer Medical Technology Corporation
Decision Date2022-02-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares is a medical device manufactured by Canadian Pioneer Medical Technology Corporation. It received FDA 510(k) clearance on 2022-02-25 under approval 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.

Frequently Asked Questions

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. It is manufactured by Canadian Pioneer Medical Technology Corporation. The 510(k) number is K211722.

When was Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares approved by the FDA?

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

What company makes Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares?

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares is manufactured by Canadian Pioneer Medical Technology Corporation.

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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Related PubMed Literature

PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Canadian Pioneer Medical Technology Corporation

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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