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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 K040871
Device Name FACEMASTER FACIAL TONING SYSTEM
Applicant
Facemaster of Beverly Hills, Inc.
Three Park Plz., Suite 1570
Irvine,  CA  92614
Applicant Contact JIM ENGLAND
Correspondent
Facemaster of Beverly Hills, Inc.
Three Park Plz., Suite 1570
Irvine,  CA  92614
Correspondent Contact JIM ENGLAND
Regulation Number882.5890
Classification Product Code
NFO  
Date Received04/02/2004
Decision Date 06/01/2005
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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