NuFACE Gel Primer
K-Number: K161654 · 2016-12-30
ApplicantCarol Cole Company
Decision Date2016-12-30
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NuFACE Gel Primer is a medical device manufactured by Carol Cole Company. It received FDA 510(k) clearance on 2016-12-30 under approval 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. It is manufactured by Carol Cole Company. The 510(k) number is K161654.
When was NuFACE Gel Primer approved by the FDA?
NuFACE Gel Primer received FDA 510(k) clearance on 2016-12-30, under approval number K161654.
What company makes NuFACE Gel Primer?
NuFACE Gel Primer is manufactured by Carol Cole Company.
What is the FDA product code for NuFACE Gel Primer?
The FDA product code for NuFACE Gel Primer is GYB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.