NuFACE Mini Plus

Q: When was NuFACE Mini Plus cleared by the FDA?

NuFACE Mini Plus (K201680) received a 510(k) decision of Substantially Equivalent on February 19, 2021, 242 days after the submission was received.

Q: What is the product code of K201680?

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) K201680 · Carole Cole Company

Substantially Equivalent

510(k) numberK201680

Submission

Device name: NuFACE Mini Plus
Applicant: Carole Cole Company
Vista, CA, US
Received: June 22, 2020
Decision date: February 19, 2021
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

Other 510(k)s with product code NFO

510(k)	Device	Applicant	Decision
K262861	PureLift Pro MaxNFO · Special	Xtreem Pulse, LLC	09/11/2026SE
K260387	SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)NFO · Traditional	Hironic Co., Ltd.	08/31/2026SE
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

Questions and answers

When was NuFACE Mini Plus cleared by the FDA?

NuFACE Mini Plus (K201680) received a 510(k) decision of Substantially Equivalent on February 19, 2021, 242 days after the submission was received.

What is the product code of K201680?

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