NuFACE Mini Plus

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Carole Cole Company

The following data is part of a premarket notification filed by Carole Cole Company with the FDA for Nuface Mini Plus.

Pre-market Notification Details

Device IDK201680
510k NumberK201680
Device Name:NuFACE Mini Plus
ClassificationStimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant Carole Cole Company 1325 Sycamore Ave, Suite A Vista,  CA  92081
ContactDanielle Barker Fernandes
CorrespondentBob Duffy
Carole Cole Company 1325 Sycamore Ave, Suite A Vista,  CA  92081
Product CodeNFO  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-22
Decision Date2021-02-19

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