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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K160821
Device Name Tria Sapphire
Applicant
Tria Beauty, Inc.
4160 Dublin Blvd., Suite 200
Dublin,  CA  94568
Applicant Contact Heather Tanner
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number878.4810
Classification Product Code
OLP  
Date Received03/24/2016
Decision Date 06/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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