Alexandrite And Nd:YAG Laser Models CANLASE And TORLASE

Powered Laser Surgical Instrument

Canadian Pioneer Medical Technology Corporation (CPMT LASER)

The following data is part of a premarket notification filed by Canadian Pioneer Medical Technology Corporation (cpmt Laser) with the FDA for Alexandrite And Nd:yag Laser Models Canlase And Torlase.

Pre-market Notification Details

Device IDK222673
510k NumberK222673
Device Name:Alexandrite And Nd:YAG Laser Models CANLASE And TORLASE
ClassificationPowered Laser Surgical Instrument
Applicant Canadian Pioneer Medical Technology Corporation (CPMT LASER) 210 Drumlin Circle, Concord Vaughan,  CA L4K 3E3
ContactRashid Reza Mir Sayah
CorrespondentRashid Reza Mir Sayah
Canadian Pioneer Medical Technology Corporation (CPMT LASER) 210 Drumlin Circle, Concord Vaughan,  CA L4K 3E3
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-06
Decision Date2022-11-17

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