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FDA 510(k)

NuFACE Mini Plus

K-Number: K201680 · 2021-02-19

ApplicantCarole Cole Company
Decision Date2021-02-19
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NuFACE Mini Plus is the device name listed in this FDA 510(k) record. The listed applicant is Carole Cole Company. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K201680. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuFACE Mini Plus?

NuFACE Mini Plus is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Carole Cole Company. The 510(k) number is K201680.

When did NuFACE Mini Plus receive FDA 510(k) clearance?

NuFACE Mini Plus received FDA 510(k) clearance on 2021-02-19, under 510(k) number K201680.

Who is the listed applicant for NuFACE Mini Plus?

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

What is the FDA product code for NuFACE Mini Plus?

The FDA product code for NuFACE Mini Plus is NFO.

Related Devices (Code: NFO)

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.

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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.

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