Product Code: NFO FDA class 2 21 CFR 882.5890

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Neurology

The Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO) is a neurology device that applies transcutaneous electrical stimulation to facial or body muscles for aesthetic purposes such as skin tightening or muscle toning, distinct from therapeutic TENS devices. It is classified as an FDA Class 2 device within the Neurology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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FEI Numbers

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Basic Information

Product Code: NFO
Device Class: FDA class 2
Regulation Number: 882.5890
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 78 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260179	VITA Multi-Function Head Brush (TB-2343F, TB-2442F)	Jun 03, 2026	Substantially Equivalent	Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
K260895	Ulike Clear Zero (YC10 BU)	May 28, 2026	Substantially Equivalent	Guangxi Ulike Medical Technology Co., Ltd.
K252621	DeepSkin (DEP100)	May 08, 2026	Substantially Equivalent	El Global Trade, Ltd.
K252187	Aura Glide (FC40)	Dec 23, 2025	Substantially Equivalent	Aura Medical, LLC
K252146	Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)	Dec 23, 2025	Substantially Equivalent	Shenzhen Siken 3D Technology Development Co., Ltd.
K250618	Medi Lift Essential Eye Mask	Oct 29, 2025	Substantially Equivalent	Ya-Man, Ltd.
K250227	JOVS Electric Stimulation Beauty Device (JE2)	Oct 17, 2025	Substantially Equivalent	Shenzhen Qianyu Technology Co., Ltd.
K251034	Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)	Oct 12, 2025	Substantially Equivalent	Shenzhen Nuon Medical Equipment Co., Ltd.
K252553	Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)	Oct 09, 2025	Substantially Equivalent	Shenzhen Jianchao Intelligent Technology Co., Ltd.
K251649	Sunny Plus (Sunny)	Sep 18, 2025	Substantially Equivalent	ShenB Co., Ltd.
K251909	NeurotriS (SX2500); NeurotriS (SX3800)	Sep 03, 2025	Substantially Equivalent	A-1 Engineering
K252218	MF SC GEN2 Facial Toning System	Jul 18, 2025	Substantially Equivalent	Micro Current Technology, Inc.
K244004	Microcurrent Facial Device (CEC101, EE0101, EEI101)	Jul 10, 2025	Substantially Equivalent	Shenzhen Dachi Communication Co., Ltd.
K250361	SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1	May 23, 2025	Substantially Equivalent	Geske Beauty Tech GmbH
K243072	Préime DermaFacial (MicroT)	Apr 01, 2025	Substantially Equivalent	EMA Aesthetics , Ltd.
K243587	PureLift GLOW	Mar 06, 2025	Substantially Equivalent	Xtreem Pulse, LLC
K243063	Myolight Microcurrent Handpiece	Feb 10, 2025	Substantially Equivalent	Raja Trading Company, Inc.
K243393	JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)	Feb 03, 2025	Substantially Equivalent	Shenzhen Ulike Smart Electronics Co., Ltd.
K244048	Medi Lift Mask	Jan 16, 2025	Substantially Equivalent	Ya-Man, Ltd.
K243430	Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)	Dec 19, 2024	Substantially Equivalent	Shenzhen Aozemei Technology Co., Ltd.
K242532	BTL-785BNF-E	Dec 13, 2024	Substantially Equivalent	BTL Industries, Inc.
K240564	NuFACE® FIX+	Jun 27, 2024	Substantially Equivalent	Carol Cole Company Dba Nuface®
K232242	BEAR 2 Body	May 13, 2024	Substantially Equivalent	Foreo, Inc.
K233667	Facial Toning device (UIC-189); Facial Toning device (UIC-589)	Feb 12, 2024	Substantially Equivalent	Body Trim Industrial Co., Ltd.
K233525	MF SC Facial Toning System	Nov 24, 2023	Substantially Equivalent	Micro Current Technology, Inc.
K233010	Beagank 4T Plus	Nov 21, 2023	Substantially Equivalent	Belega, Inc.
K232001	Nu Skin RenuSpa iO	Nov 21, 2023	Substantially Equivalent	Nse Products, Inc.
K230459	C.C. Life 21	Oct 19, 2023	Substantially Equivalent	21 Equipment S.R.L.
K232172	BTL-785BNF Handpiece	Sep 18, 2023	Substantially Equivalent	BTL Industries, Inc.
K220198	Medi Lift PLUS	Jun 28, 2023	Substantially Equivalent	Ya-Man, Ltd.
K230506	PureLift Pro Edition	Jun 21, 2023	Substantially Equivalent	Xtreem Pulse
K213078	Myolift QT	Apr 27, 2023	Substantially Equivalent	Johari Digital Healthcare Limited
K221443	PureLift Pro Plus	Oct 21, 2022	Substantially Equivalent	Xtreem Pulse, LLC
K214100	Luminice	Feb 24, 2022	Substantially Equivalent	Premier North America, Inc.
K211055	Microcurrent device (Model: HBR2-1)	Nov 05, 2021	Substantially Equivalent	Shenzhen DJ Medical Equipment Co., Ltd.
K212238	TheraFace Microcurrent	Sep 29, 2021	Substantially Equivalent	Theragun, Inc.
K212342	ZIIP+ Device	Sep 23, 2021	Substantially Equivalent	Ziip, Inc.
K191951	Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device	Apr 27, 2021	Substantially Equivalent	Avazzia, Inc.
K201906	Trinity ELE Plus and Trinity ELE Plus Pro	Feb 24, 2021	Substantially Equivalent	Carol Cole Company Dba Nuface
K201680	NuFACE Mini Plus	Feb 19, 2021	Substantially Equivalent	Carole Cole Company
K201782	NuFace Trinity Plus Device	Jan 22, 2021	Substantially Equivalent	Carol Cole Company Dba Nuface
K192077	Tua Face Fitness / Tua Trend Face	Sep 30, 2020	Substantially Equivalent	Vupiesse S.R.L
K200803	BEAR and BEAR mini	Jul 31, 2020	Substantially Equivalent	Foreo, Inc.
K191672	NuFACE Mini Device	Oct 15, 2019	Substantially Equivalent	Carol Cole Company Dba Nuface
K190269	PureLift	Aug 28, 2019	Substantially Equivalent	Xtreem Pulse, LLC
K183189	Ultra OTC Facial Toning System	Apr 17, 2019	Substantially Equivalent	Micro Current Technology, Inc.
K182424	NuFACE FIX Skin Toning Device	Dec 18, 2018	Substantially Equivalent	Carol Cole Company Dba Nuface
K181008	NuFACE Trinity	Oct 11, 2018	Substantially Equivalent	Carol Cole Company Dba Nuface
K181062	Ultra Facial Toning System	Jul 18, 2018	Substantially Equivalent	Micro Current Technology, Inc.
K173093	TAMA BEMS device	Jun 05, 2018	Substantially Equivalent	Tama Research Corporation
K171821	2 Face / Face Evolution	Apr 26, 2018	Substantially Equivalent	Heat IN A Click
K163550	Pobling MIITY 2	Dec 20, 2017	Substantially Equivalent	Habalan Med & Beauty Co.,Ltd
K162652	Smart Photon Micro-current Device, Model: EP-300	Oct 25, 2017	Substantially Equivalent	Li-Tek Electronic Technology Corporation
K171647	BeneLife Premium Facial Treatment Pack, Model: QZ0701A	Oct 23, 2017	Substantially Equivalent	Infinitus (China) Company , Ltd.
K171588	NuBODY Skin Toning Device	Jul 31, 2017	Substantially Equivalent	Carol Cole Company Dba Nuface
K163470	Galvanic Spa, Model: SKB-1405	Jun 02, 2017	Substantially Equivalent	Shenzhen Siken 3D Technology Development Co., Ltd.
K161484	ZIIP Device	Feb 24, 2017	Substantially Equivalent	Ziip,Llc
K162106	Micro-current Wrinkle Reduction Facial service, model EP-400	Feb 03, 2017	Substantially Equivalent	Li-Tek Electronic Technology Corporation
K152199	RejuvatoneMD	Mar 23, 2016	Substantially Equivalent	Trophy Skin, Inc.
K150826	Nutra Face Lift Model PE8050	Feb 10, 2016	Substantially Equivalent	Nutra Luxe MD, LLC
K150077	SonicLift	Nov 25, 2015	Substantially Equivalent	Pretika Corporation
K142794	Everyway Facial MENS	Jun 02, 2015	Substantially Equivalent	Everyway Medical Instruments Co.,Ltd
K130065	BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE	Apr 30, 2014	Substantially Equivalent	Biosonic Technologies, LLC
K133823	NUFACE MINI DEVICE	Apr 17, 2014	Substantially Equivalent	Carol Cole Company
K131251	TRINITY ELE	Oct 01, 2013	Substantially Equivalent	Carol Cole Company
K122711	FACIAL SPA	Sep 17, 2013	Substantially Equivalent	Nuskin
K120511	AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM	Jul 30, 2012	Substantially Equivalent	Leto Enterprise , Ltd.
K112351	ULTRA BEAUTY	Mar 30, 2012	Substantially Equivalent	Johari Digital Healthcare , Ltd.
K113724	ELECTROPULSE-COSMETIC	Feb 15, 2012	Substantially Equivalent	Pain Relief Technologies
K102494	THE BUZZ FACIAL TONING SYSTEM	Dec 09, 2011	Substantially Equivalent	Daka International , Ltd.
K103031	BMR FACE	Nov 10, 2011	Substantially Equivalent	Bio-Medical Research, Ltd.
K103472	NUFACE PLUS	Nov 07, 2011	Substantially Equivalent	Carol Cole Company
K071573	RUGALIFT, MODEL# V.2.1	Dec 09, 2008	Substantially Equivalent	Fatrotek S.R.L.
K070250	NUTRITONE FACIAL BEAUTY SYSTEM	Sep 04, 2008	Substantially Equivalent	Isomers Laboratories, Inc.
K070217	INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE	Apr 04, 2008	Substantially Equivalent	Neuro Resource Group, Inc.
K072260	NUFACE, MODEL NU-4003	Nov 27, 2007	Substantially Equivalent	Carol Cole Company
K040871	FACEMASTER FACIAL TONING SYSTEM	Jun 01, 2005	Substantially Equivalent	Facemaster of Beverly Hills, Inc.
K011935	REJUVENIQUE MODEL #RJV10	Aug 08, 2001	Substantially Equivalent	Salton, Inc.