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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
510(k) Number K120737
Device Name TRIA LASER HAIR REMOVAL SYSTEM
Applicant
TRIA BEAUTY, INC.
555 13TH STREET, NW
COLUMBIA SQUARE
WASHINGTON,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
TRIA BEAUTY, INC.
555 13TH STREET, NW
COLUMBIA SQUARE
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN KAHAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/09/2012
Decision Date 09/13/2012
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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