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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 K133945
Device Name CUTERA PICOSECOND LASER SYSTEM
Original Applicant
CUTERA, INC.
3240 bayshore blvd
brisbane,  CA  94005
Original Contact bradley renton
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/23/2013
Decision Date 08/11/2014
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
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