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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K151816
FOIA Releasable 510(k) K151816
Device Name TLC-2000 Therapeutic Medical Laser System
Applicant
Theralase, Inc.
1945 Queen St. E.
Toronto,  CA
Applicant Contact Roger Dumoulin-White
Correspondent
Theralase, Inc.
1945 Queen St. E.
Toronto,  CA
Correspondent Contact Roger Dumoulin-White
Regulation Number890.5500
Classification Product Code
NHN  
Date Received07/06/2015
Decision Date 11/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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