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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
Device Name ISOLAZ 2 INTENSE PULSED LIGHT 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
ONF  
Date Received05/22/2012
Decision Date 06/05/2012
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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