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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
Device Name CLEAR + BRILLIANT LASER SYSTEM
Applicant
SOLTA MEDICAL, INC.
25881 INDUSTRIAL BLVD
HAYWARD,  CA  94545
Applicant Contact KRISTINE FOSS
Correspondent
SOLTA MEDICAL, INC.
25881 INDUSTRIAL BLVD
HAYWARD,  CA  94545
Correspondent Contact KRISTINE FOSS
Regulation Number878.4810
Classification Product Code
ONG  
Date Received02/13/2012
Decision Date 04/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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