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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 K130459
Device Name TRIA FAN 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
ONG  
Date Received02/22/2013
Decision Date 10/25/2013
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
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