Laser Treatment System, Model: NYX And Grace

Powered Laser Surgical Instrument

Canadian Pioneer Medical Technology Corporation

The following data is part of a premarket notification filed by Canadian Pioneer Medical Technology Corporation with the FDA for Laser Treatment System, Model: Nyx And Grace.

Pre-market Notification Details

Device IDK210033
510k NumberK210033
Device Name:Laser Treatment System, Model: NYX And Grace
ClassificationPowered Laser Surgical Instrument
Applicant Canadian Pioneer Medical Technology Corporation Unit 2 -210 Drumlin Circle, Concord Vaughan,  CA L4k 3e3
ContactRashid Reza Mirsayah
CorrespondentRashid Reza Mir Sayah
Canadian Pioneer Medical Technology Corporation Unit 2, 210 Drumlin Circle, Concord Vaughan,  CA L4k 3e3
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-05
Decision Date2021-02-26

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