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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument With Microbeam\Fractional Output
510(k) Number K141868
Device Name TRIA FANP
Applicant
Tria Beauty, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
Tria Beauty, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN KAHAN
Regulation Number878.4810
Classification Product Code
ONG  
Date Received07/10/2014
Decision Date 12/30/2014
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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