NuFACE Mini Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K191672 ↗

FDA Product Code

NFO

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• NuFace Trinity Plus Device

  Class II

  FDA 510(k) K201782 Active Cleared 22 Jan 2021

• NuFACE FIX Skin Toning Device

  Class II

  FDA 510(k) K182424 Active Cleared 18 Dec 2018

• NuFACE Trinity

  Class II

  FDA 510(k) K181008 Active Cleared 11 Oct 2018

• Trinity Plus Wrinkle Reducer

  Class II

  FDA 510(k) K212947 Active Cleared 2 Apr 2022

• NuBODY Skin Toning Device

  Class II

  FDA 510(k) K171588 Active Cleared 31 Jul 2017

• Trinity ELE Plus and Trinity ELE Plus Pro

  Class II

  FDA 510(k) K201906 Active Cleared 24 Feb 2021

See all devices from Carol Cole Company dba NuFACE →

• What is the primary purpose of the NuFACE Mini Device and how does it work?

  The NuFACE Mini Device is a transcutaneous electrical stimulator (TENS-like) designed for aesthetic facial use. It delivers microcurrent therapy to gently stimulate facial muscles and tissues, aiming to improve skin tone, reduce sagging, and minimize signs of aging through non-invasive electrical impulses. It’s intended for home use and targets facial rejuvenation without surgery or invasive procedures.

• Is the NuFACE Mini Device reusable or single-use, and what are its sterility requirements?

  The NuFACE Mini Device is explicitly labeled as a reusable, non-sterile medical device. Since it’s intended for single-user application at home, it does not require sterile packaging or conditions. However, standard hygiene practices (e.g., cleaning between uses) should be followed to maintain safety and effectiveness.

• Are there any special storage conditions for the NuFACE Mini Device, and can it be used near MRI machines?

  The device requires no special storage conditions—it can be stored at room temperature without restrictions. Additionally, there are no MRI safety restrictions specified, meaning it can be used in environments where MRI scans are performed without interference.

• How is the NuFACE Mini Device regulated, and what does its FDA clearance mean for users?

  The NuFACE Mini Device holds FDA clearance (K191672) under a 510(k) submission, classified as a Class II Neurology device with Product Code NFO. This clearance confirms it meets FDA standards for safety and effectiveness as a transcutaneous electrical stimulator for aesthetic facial use, but it does not imply medical treatment of disease—only cosmetic/toning benefits.