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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 K050397
Device Name VELASMOOTH, SHAPER
Applicant
Syneron Medical, Ltd.
601 Pennsylvania Ave., NW
Washington,  DC  20004
Applicant Contact DONALD E SEGAL
Correspondent
Syneron Medical, Ltd.
601 Pennsylvania Ave., NW
Washington,  DC  20004
Correspondent Contact DONALD E SEGAL
Regulation Number878.4810
Classification Product Code
NUV  
Date Received02/16/2005
Decision Date 06/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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