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FDA 510(k)

NuFACE® FIX+

K-Number: K240564 · 2024-06-27

ApplicantCarol Cole Company Dba Nuface®
Decision Date2024-06-27
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NuFACE® FIX+ is a medical device manufactured by Carol Cole Company Dba Nuface®. It received FDA 510(k) clearance on 2024-06-27 under approval number K240564. 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® FIX+?

NuFACE® FIX+ is a medical device that received FDA 510(k) clearance on 2024-06-27. It is manufactured by Carol Cole Company Dba Nuface®. The 510(k) number is K240564.

When was NuFACE® FIX+ approved by the FDA?

NuFACE® FIX+ received FDA 510(k) clearance on 2024-06-27, under approval number K240564.

What company makes NuFACE® FIX+?

NuFACE® FIX+ is manufactured by Carol Cole Company Dba Nuface®.

What is the FDA product code for NuFACE® FIX+?

The FDA product code for NuFACE® FIX+ is NFO.

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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.

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