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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K150554
Device Name NuBrilliance Light Pain Therapy
Applicant
Wellquest International, Inc.
230 Fifth Ave.
Suite 800
New York,  NY  10001
Applicant Contact YVETH KAN
Correspondent
Emergo Global Consulting, LLC
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact CARRIE HETRICK
Regulation Number890.5500
Classification Product Code
ILY  
Date Received03/04/2015
Decision Date 10/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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