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FDA 510(k) Application Details - K130459
Device Classification Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
More FDA Info for this Device
510(K) Number
K130459
Device Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant
TRIA BEAUTY, INC.
555 13TH STREET, NW
COLUMBIA SQUARE
WASHINGTON, DC 20004 US
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Contact
JONATHAN KAHAN
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
ONG
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More FDA Info for this Product Code
Date Received
02/22/2013
Decision Date
10/25/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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