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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 K130065
Device Name BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
Applicant
BIOSONIC TECHNOLOGIES, LLC
28241 CROWN VALLEY PARKWAY
SUITE 510(K)
LAGUNA NIGUEL,  CA  92677
Applicant Contact SHEPARD G BENTLEY
Correspondent
BIOSONIC TECHNOLOGIES, LLC
28241 CROWN VALLEY PARKWAY
SUITE 510(K)
LAGUNA NIGUEL,  CA  92677
Correspondent Contact SHEPARD G BENTLEY
Regulation Number882.5890
Classification Product Code
NFO  
Date Received01/10/2013
Decision Date 04/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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