Nuface Mini Device

Q: When was Nuface Mini Device cleared by the FDA?

Nuface Mini Device (K133823) received a 510(k) decision of Substantially Equivalent on April 17, 2014, 121 days after the submission was received.

Q: What is the product code of K133823?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.

FDA 510(k) K133823 · Carol Cole Company

Substantially Equivalent

510(k) numberK133823

Submission

Device name: Nuface Mini Device
Applicant: Carol Cole Company
Vista, CA, US
Received: December 17, 2013
Decision date: April 17, 2014
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5890
Specialty: Neurology

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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
K161654	NuFACE Gel PrimerGYB · Traditional	12/30/2016SE
K131251	Trinity EleNFO · Traditional	10/01/2013SE
K120560	Trinity Wrinkle RemoverOHS · Traditional	11/06/2012SE
K103472	Nuface PlusNFO · Abbreviated	11/07/2011SE
K072260	Nuface, Model NU-4003NFO · Traditional	11/27/2007SE

Questions and answers

When was Nuface Mini Device cleared by the FDA?

Nuface Mini Device (K133823) received a 510(k) decision of Substantially Equivalent on April 17, 2014, 121 days after the submission was received.

What is the product code of K133823?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.