PureLase

GUDID 00198715225501

Canadian Pioneer Medical Technology Corporation

General/multiple surgical carbon dioxide laser system
Primary Device ID00198715225501
NIH Device Record Keyb89568a0-55d0-495e-b5c1-9f63e47681e3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureLase
Version Model NumberPureLase
Company DUNS204132773
Company NameCanadian Pioneer Medical Technology Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100198715225501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-08
Device Publish Date2025-06-30

Devices Manufactured by Canadian Pioneer Medical Technology Corporation

00199284314580 - CPMT Ares – Quadruple Laser System2025-07-16 CPMT Ares is a quadruple-wavelength semiconductor laser system featuring four separate handpieces: 755 nm Alexandrite, 808 nm Di
00199284747210 - TORLASE-Alexandrite and Nd: Yag laser 2025-07-16 TORLASE is a dual-wavelength long-pulse laser system combining Alexandrite (755 nm) and Nd:YAG (1064 nm) technologies for advanc
00198715225501 - PureLase 2025-07-08
00198715225501 - PureLase 2025-07-08
00199284910331 - EMS2025-07-08 MagnaCore is a non-invasive EMS device that uses electromagnetic pulses to strengthen and tone muscles. It targets areas such as
00198715809718 - CPMT AquaPro2025-07-03
00198715351606 - CPMT AquaPro2025-01-08

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