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FDA 510(k)

Laser Treatment System, Model: NYX and Grace

K-Number: K210033 · 2021-02-26

ApplicantCanadian Pioneer Medical Technology Corporation
Decision Date2021-02-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Laser Treatment System, Model: NYX and Grace 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 2021-02-26 under 510(k) 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. The listed applicant is Canadian Pioneer Medical Technology Corporation. The 510(k) number is K210033.

When did Laser Treatment System, Model: NYX and Grace receive FDA 510(k) clearance?

Laser Treatment System, Model: NYX and Grace received FDA 510(k) clearance on 2021-02-26, under 510(k) number K210033.

Who is the listed applicant for Laser Treatment System, Model: NYX and Grace?

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: NYX and Grace?

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

Other records listing Canadian Pioneer Medical Technology Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresK212793Laser Treatment System, Model: Hera, Armo

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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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