TLC-2000 Therapeutic Medical Laser System— 510(k) K151816

Substantially Equivalent

Theralase, Inc.

FDA 510(k) clearance K151816 for TLC-2000 Therapeutic Medical Laser System, Substantially Equivalent on 2015-11-19. Applicant: Theralase, Inc..

Clearance details

Applicant: Theralase, Inc.
Product code: Code NHN
Advisory panel: Physical Medicine
Date received: 2015-07-06
Decision date: 2015-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

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