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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 K232133
Device Name Co2 Laser System, Models: PureLase And VanLase
Applicant
Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
460 Garyray Dr., N. York
Toronto,  CA M9L 1P8
Applicant Contact Rashid Reza Mir Sayah
Correspondent
Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
460 Garyray Dr., N. York
Toronto,  CA M9L 1P8
Correspondent Contact Rashid Reza Mir Sayah
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/18/2023
Decision Date 04/16/2024
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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