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FDA 510(k) K151816, TLC-2000 Therapeutic Medical Laser System, by Theralase, Inc.

FDA 510(k) K151816, TLC-2000 Therapeutic Medical Laser System, by Theralase, Inc.

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510(K) Number: K151816
Device Name: TLC-2000 Therapeutic Medical Laser System
Manufacturer: Theralase, Inc.
Device Classification Name: powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
Regulation Number: 890.5500
Classification Product Code: NHN
Date Received: 07/06/2015
Decision Date: 11/19/2015
Regulation Medical Specialty: Physical Medicine
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