FDA 510(k)

NuFACE Gel Primer

K-Number: K161654 · 2016-12-30

Decision Date2016-12-30

Product CodeGYB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NuFACE Gel Primer is the device name listed in this FDA 510(k) record. The listed applicant is Carol Cole Company. It received FDA 510(k) clearance on 2016-12-30 under 510(k) number K161654. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuFACE Gel Primer?

NuFACE Gel Primer is a medical device that received FDA 510(k) clearance on 2016-12-30. The listed applicant is Carol Cole Company. The 510(k) number is K161654.

When did NuFACE Gel Primer receive FDA 510(k) clearance?

NuFACE Gel Primer received FDA 510(k) clearance on 2016-12-30, under 510(k) number K161654.

Who is the listed applicant for NuFACE Gel Primer?

The FDA 510(k) record lists Carol Cole Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NuFACE Gel Primer?

The FDA product code for NuFACE Gel Primer is GYB.

Related Devices (Code: GYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.K222770Conductive GelTop-Rank Health Care Co., Ltd.K221724Conductive GelTone-A-Matic International, Inc.K212325EEG-acpSomnomedics GmbH K212326AC Cream - Conductive pasteSpes Medica Srl

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.