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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 K120433
Model CB-CONSOLE, CB-HAND PIECE(S)- 1440 OR 1927, CB-TIPS
Device Name CLEAR + BRILLIANT LASER SYSTEM
Original Applicant
SOLTA MEDICAL, INC.
25881 industrial blvd
hayward,  CA  94545
Original Contact kristine foss
Regulation Number878.4810
Classification Product Code
ONG  
Date Received02/15/2012
Decision Date 04/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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