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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
Theralase Inc.
1945 Queen Street East
Toronto,  CA
Applicant Contact Roger Dumoulin-White
Theralase Inc.
1945 Queen Street East
Toronto,  CA
Correspondent Contact Roger Dumoulin-White
Regulation Number890.5500
Classification Product Code
Date Received07/06/2015
Decision Date 11/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls