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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name over-the-counter powered light based laser for acne
510(k) Number K121435
Device Name SILKN BLUE
Original Applicant
tavor buld. pob 533
yokneam illit,  IS 20692
Original Contact amir waldman
Regulation Number878.4810
Classification Product Code
Date Received05/14/2012
Decision Date 02/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No