Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NuFACE FIX Skin Toning Device

K-Number: K182424 · 2018-12-18

Decision Date2018-12-18
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NuFACE FIX Skin Toning Device is the device name listed in this FDA 510(k) record. The listed applicant is Carol Cole Company Dba Nuface. It received FDA 510(k) clearance on 2018-12-18 under 510(k) number K182424. 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 Skin Toning Device?

NuFACE FIX Skin Toning Device is a medical device that received FDA 510(k) clearance on 2018-12-18. The listed applicant is Carol Cole Company Dba Nuface. The 510(k) number is K182424.

When did NuFACE FIX Skin Toning Device receive FDA 510(k) clearance?

NuFACE FIX Skin Toning Device received FDA 510(k) clearance on 2018-12-18, under 510(k) number K182424.

Who is the listed applicant for NuFACE FIX Skin Toning Device?

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

What is the FDA product code for NuFACE FIX Skin Toning Device?

The FDA product code for NuFACE FIX Skin Toning Device is NFO.

Other records listing Carol Cole Company Dba Nuface as applicant

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.

View all 8 devices →

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.

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.