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FDA 510(k)

Co2 Laser System, Models: PureLase And VanLase

K-Number: K232133 · 2024-04-16

ApplicantCpmt Laser (Canadian Pioneer Medical Technology Corporation)
Decision Date2024-04-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Co2 Laser System, Models: PureLase And VanLase is a medical device manufactured by Cpmt Laser (Canadian Pioneer Medical Technology Corporation). It received FDA 510(k) clearance on 2024-04-16 under approval number K232133. 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 Co2 Laser System, Models: PureLase And VanLase?

Co2 Laser System, Models: PureLase And VanLase is a medical device that received FDA 510(k) clearance on 2024-04-16. It is manufactured by Cpmt Laser (Canadian Pioneer Medical Technology Corporation). The 510(k) number is K232133.

When was Co2 Laser System, Models: PureLase And VanLase approved by the FDA?

Co2 Laser System, Models: PureLase And VanLase received FDA 510(k) clearance on 2024-04-16, under approval number K232133.

What company makes Co2 Laser System, Models: PureLase And VanLase?

Co2 Laser System, Models: PureLase And VanLase is manufactured by Cpmt Laser (Canadian Pioneer Medical Technology Corporation).

What is the FDA product code for Co2 Laser System, Models: PureLase And VanLase?

The FDA product code for Co2 Laser System, Models: PureLase And VanLase is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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)

Other Devices by Cpmt Laser (Canadian Pioneer Medical Technology Corporation)

K241601EMS (FlexPulse, MagnaCore, Magnetika)

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Official Source

View on FDA Database →

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

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