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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 K212793
Device Name Laser Treatment System, Model: Hera, Armo
Applicant
Canadian Pioneer Medical Technology Corporation
Unit 2, 210 Drumlin Circle, Concord
Vaughan,  CA L4k 3E3
Applicant Contact Rashid Reza Mir Sayah
Correspondent
Canadian Pioneer Medical Technology Corporation
Unit 2, 210 Drumlin Circle, Concord
Vaughan,  CA L4k 3E3
Correspondent Contact Rashid Reza Mir Sayah
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/01/2021
Decision Date 10/25/2021
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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