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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 K201782
Device Name NuFace Trinity Plus Device
Applicant
Carol Cole Company Dba Nuface
1325 Sycamore Ave.
Suite A
Vista,  CA  92081
Applicant Contact Danielle Barker Fernandes
Correspondent
Bob Duffy Associates, Inc.
16405 Summer Sage Rd.
Poway,  CA  92064
Correspondent Contact Bob Duffy
Regulation Number882.5890
Classification Product Code
NFO  
Date Received06/30/2020
Decision Date 01/22/2021
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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