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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name massager, vacuum, radio frequency induced heat
510(k) Number K122389
Device Name TRUSCULPT
Original Applicant
CUTERA, INC.
3240 bayshore blvd
brisbane,  CA  94005
Original Contact connie hoy
Regulation Number878.4400
Classification Product Code
PBX  
Date Received08/10/2012
Decision Date 11/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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