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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 K201680
Device Name NuFACE Mini Plus
Applicant
Carole Cole Company
1325 Sycamore Ave, Suite A
Vista,  CA  92081
Applicant Contact Danielle Barker Fernandes
Correspondent
Carole Cole Company
1325 Sycamore Ave, Suite A
Vista,  CA  92081
Correspondent Contact Bob Duffy
Regulation Number882.5890
Classification Product Code
NFO  
Date Received06/22/2020
Decision Date 02/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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