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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K102494
Device Name THE BUZZ FACIAL TONING SYSTEM
Applicant
Daka International , Ltd.
1131 Anthem View Ln.
Knoxville,  TN  37922
Applicant Contact BOB WAGNER
Correspondent
Daka International , Ltd.
1131 Anthem View Ln.
Knoxville,  TN  37922
Correspondent Contact BOB WAGNER
Regulation Number882.5890
Classification Product Code
NFO  
Date Received08/31/2010
Decision Date 12/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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