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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 K181062
Device Name Ultra Facial Toning System
Micro Current Technology, Inc.
2244 1st Ave. South
Seattle,  WA  98134
Applicant Contact David Suzuki
Regulatory Insight, Inc
2244 1st Ave. South
Seattle,  WA  98134
Correspondent Contact David Suzuki
Regulation Number882.5890
Classification Product Code
Date Received04/23/2018
Decision Date 07/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No