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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name massager, vacuum, light induced heating
510(k) Number K122579
Device Name VELASHAPE
Original Applicant
SYNERON MEDICAL LTD.
industrial zone
tavor bldg p.o.b 550
yokneam, illit,  IS 20692
Original Contact sam wade
Regulation Number878.4810
Classification Product Code
NUV  
Date Received08/30/2012
Decision Date 09/13/2012
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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