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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K211722
Device Name Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
Applicant
Canadian Pioneer Medical Technology Corporation
Unit 2 -210 Drumlin Cir., Concord
Vaughan,  CA L4K 3E3
Applicant Contact Rashid Reza Mir Reza Mir
Correspondent
Canadian Pioneer Medical Technology Corporation
Unit 2 -210 Drumlin Cir., Concord
Vaughan,  CA L4K 3E3
Correspondent Contact Rashid Reza Mir Reza Mir
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/04/2021
Decision Date 02/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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