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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K121515
Model ISOLAZ 2 CONSOLE, CART, HANDPIECE AND TIPS
Device Name ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
Original Applicant
SOLTA MEDICAL, INC.
25881 industrial blvd
hayward,  CA  94545
Original Contact kristine foss
Regulation Number878.4810
Classification Product Code
ONF  
Date Received05/22/2012
Decision Date 06/05/2012
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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