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 a medical device manufactured by Carol Cole Company Dba Nuface. It received FDA 510(k) clearance on 2018-12-18 under approval 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. It is manufactured by Carol Cole Company Dba Nuface. The 510(k) number is K182424.

When was NuFACE FIX Skin Toning Device approved by the FDA?

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

What company makes NuFACE FIX Skin Toning Device?

NuFACE FIX Skin Toning Device is manufactured by Carol Cole Company Dba Nuface.

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 Devices by Carol Cole Company Dba Nuface

K171588NuBODY Skin Toning Device K181008NuFACE Trinity K191672NuFACE Mini Device K201906Trinity ELE Plus and Trinity ELE Plus Pro K201782NuFace Trinity Plus Device K212947Trinity Plus Wrinkle Reducer

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Related Devices (Code: NFO)

K152199RejuvatoneMDTrophy Skin, Inc. K150826Nutra Face Lift Model PE8050Nutra Luxe MD, LLC K163550Pobling MIITY 2Habalan Med & Beauty Co.,Ltd K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation K171647BeneLife Premium Facial Treatment Pack, Model: QZ0701AInfinitus (China) Company , Ltd. K171588NuBODY Skin Toning DeviceCarol Cole Company Dba Nuface

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.