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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Led Accessory
510(k) Number K143120
Device Name OrthoPulse
Applicant
Biolux Research , Ltd.
825 Powell St., Suite 220
Vancouver,  CA V6A 1H7
Applicant Contact Kevin Strange
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number872.5470
Classification Product Code
PLH  
Date Received10/30/2014
Decision Date 07/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Clinical Trials NCT02267811
NCT02267824
NCT02267837
NCT02267850
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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