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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 K120511
Device Name AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
Applicant
LETO ENTERPRISE LTD.
308 HENNESSY RD
WANCHAI,  HK HONGKONG
Applicant Contact SABRINA WEI
Correspondent
LETO ENTERPRISE LTD.
308 HENNESSY RD
WANCHAI,  HK HONGKONG
Correspondent Contact SABRINA WEI
Regulation Number882.5890
Classification Product Code
NFO  
Date Received02/21/2012
Decision Date 07/30/2012
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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