NuFACE FIX Skin Toning Device
FDA 510(k) K182424 · Carol Cole Company Dba Nuface
510(k) numberK182424
Submission
- Device name
- NuFACE FIX Skin Toning Device
- Applicant
- Carol Cole Company Dba Nuface
Vista, CA, US - Received
- September 6, 2018
- Decision date
- December 18, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253932 | FACEGYM Pro Device (HD-109)NFO · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 07/23/2026SE |
| K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F)NFO · Traditional | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 06/03/2026SE |
| K260895 | Ulike Clear Zero (YC10 BU)NFO · Traditional | Guangxi Ulike Medical Technology Co., Ltd. | 05/28/2026SE |
| K252621 | DeepSkin (DEP100)NFO · Traditional | El Global Trade, Ltd. | 05/08/2026SE |
| K252187 | Aura Glide (FC40)NFO · Traditional | Aura Medical, LLC | 12/23/2025SE |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…NFO · Traditional | Shenzhen Siken 3D Technology Development Co., Ltd. | 12/23/2025SE |
| K250618 | Medi Lift Essential Eye MaskNFO · Traditional | Ya-Man, Ltd. | 10/29/2025SE |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2)NFO · Traditional | Shenzhen Qianyu Technology Co., Ltd. | 10/17/2025SE |
More from Shenzhen Qianyu Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K240564 | NuFACE® FIX+NFO · Traditional | 06/27/2024SE |
| K212947 | Trinity Plus Wrinkle ReducerOHS · Traditional | 04/02/2022SE |
| K201906 | Trinity ELE Plus and Trinity ELE Plus ProNFO · Traditional | 02/24/2021SE |
| K201782 | NuFace Trinity Plus DeviceNFO · Traditional | 01/22/2021SE |
| K191672 | NuFACE Mini DeviceNFO · Traditional | 10/15/2019SE |
| K181008 | NuFACE TrinityNFO · Traditional | 10/11/2018SE |
| K171588 | NuBODY Skin Toning DeviceNFO · Traditional | 07/31/2017SE |
Questions and answers
When was NuFACE FIX Skin Toning Device cleared by the FDA?
NuFACE FIX Skin Toning Device (K182424) received a 510(k) decision of Substantially Equivalent on December 18, 2018, 103 days after the submission was received.
What is the product code of K182424?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.