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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
Applicant
SYNERON MEDICAL LTD.
INDUSTRIAL ZONE
TAVOR BLDG P.O.B 550
YOKNEAM, ILLIT,  IL 20692
Applicant Contact SAM WADE
Correspondent
SYNERON MEDICAL LTD.
INDUSTRIAL ZONE
TAVOR BLDG P.O.B 550
YOKNEAM, ILLIT,  IL 20692
Correspondent Contact SAM WADE
Regulation Number878.4810
Classification Product Code
NUV  
Date Received08/23/2012
Decision Date 09/13/2012
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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