Stimulator, Transcutaneous Electrical, Aesthetic Purposes
FDA product code NFO · Class II (moderate risk) · 21 CFR 882.5890 · Neurology
81510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Carol Cole Company Dba Nuface 7
- Xtreem Pulse, LLC 5
- Carol Cole Company 4
- Micro Current Technology, Inc. 4
- Ya-Man, Ltd. 3
- Shenzhen Siken 3D Technology Development Co., Ltd. 2
- Ziip, Inc. 2
- Li-Tek Electronic Technology Corporation 2
- Johari Digital Healthcare , Ltd. 2
- BTL Industries, Inc. 2
- Foreo, Inc. 2
- Leto Enterprise , Ltd. 1
- Everyway Medical Instruments Co.,Ltd 1
- Biosonic Technologies, LLC 1
- Nuskin 1
- Daka International , Ltd. 1
- Hironic Co., Ltd. 1
- Fatrotek S.R.L. 1
- Isomers Laboratories, Inc. 1
- Neuro Resource Group, Inc. 1
510(k) clearances
| 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 |
| K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand…NFO · Traditional | Shenzhen Nuon Medical Equipment Co., Ltd. | 10/12/2025SE |
| K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15…NFO · Traditional | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 10/09/2025SE |
| K251649 | Sunny Plus (Sunny)NFO · Traditional | ShenB Co., Ltd. | 09/18/2025SE |
| K251909 | NeurotriS (SX2500); NeurotriS (SX3800)NFO · Traditional | A-1 Engineering | 09/03/2025SE |
| K252218 | MF SC GEN2 Facial Toning SystemNFO · Special | Micro Current Technology, Inc. | 07/18/2025SE |
| K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101)NFO · Traditional | Shenzhen Dachi Communication Co., Ltd. | 07/10/2025SE |
| K250361 | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1NFO · Traditional | Geske Beauty Tech GmbH | 05/23/2025SE |
| K243072 | Préime DermaFacial (MicroT)NFO · Traditional | EMA Aesthetics , Ltd. | 04/01/2025SE |
| K243587 | PureLift GLOWNFO · Traditional | Xtreem Pulse, LLC | 03/06/2025SE |
| K243063 | Myolight Microcurrent HandpieceNFO · Traditional | Raja Trading Company, Inc. | 02/10/2025SE |
| K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)NFO · Traditional | Shenzhen Ulike Smart Electronics Co., Ltd. | 02/03/2025SE |
| K244048 | Medi Lift MaskNFO · Special | Ya-Man, Ltd. | 01/16/2025SE |
| K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)NFO · Traditional | Shenzhen Aozemei Technology Co., Ltd. | 12/19/2024SE |
| K242532 | BTL-785BNF-ENFO · Traditional | BTL Industries, Inc. | 12/13/2024SE |
| K240564 | NuFACE® FIX+NFO · Traditional | Carol Cole Company Dba Nuface® | 06/27/2024SE |
| K232242 | BEAR 2 BodyNFO · Traditional | Foreo, Inc. | 05/13/2024SE |
| K233667 | Facial Toning device (UIC-189); Facial Toning device (UIC-589)NFO · Traditional | Body Trim Industrial Co., Ltd. | 02/12/2024SE |
| K233525 | MF SC Facial Toning SystemNFO · Traditional | Micro Current Technology, Inc. | 11/24/2023SE |
| K233010 | Beagank 4T PlusNFO · Traditional | Belega, Inc. | 11/21/2023SE |
| K232001 | Nu Skin RenuSpa iONFO · Traditional | Nse Products, Inc. | 11/21/2023SE |
| K230459 | C.C. Life 21NFO · Traditional | 21 Equipment S.R.L. | 10/19/2023SE |
| K232172 | BTL-785BNF HandpieceNFO · Traditional | BTL Industries, Inc. | 09/18/2023SE |
| K220198 | Medi Lift PLUSNFO · Traditional | Ya-Man, Ltd. | 06/28/2023SE |
| K230506 | PureLift Pro EditionNFO · Special | Xtreem Pulse | 06/21/2023SE |
| K213078 | Myolift QTNFO · Traditional | Johari Digital Healthcare Limited | 04/27/2023SE |
| K221443 | PureLift Pro PlusNFO · Special | Xtreem Pulse, LLC | 10/21/2022SE |
| K214100 | LuminiceNFO · Traditional | Premier North America, Inc. | 02/24/2022SE |
| K211055 | Microcurrent device (Model: HBR2-1)NFO · Traditional | Shenzhen DJ Medical Equipment Co., Ltd. | 11/05/2021SE |
| K212238 | TheraFace MicrocurrentNFO · Traditional | Theragun, Inc. | 09/29/2021SE |
| K212342 | ZIIP+ DeviceNFO · Traditional | Ziip, Inc. | 09/23/2021SE |
| K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT DeviceNFO · Traditional | Avazzia, Inc. | 04/27/2021SE |
| K201906 | Trinity ELE Plus and Trinity ELE Plus ProNFO · Traditional | Carol Cole Company Dba Nuface | 02/24/2021SE |
| K201680 | NuFACE Mini PlusNFO · Abbreviated | Carole Cole Company | 02/19/2021SE |
| K201782 | NuFace Trinity Plus DeviceNFO · Traditional | Carol Cole Company Dba Nuface | 01/22/2021SE |
| K192077 | Tua Face Fitness / Tua Trend FaceNFO · Traditional | Vupiesse S.R.L | 09/30/2020SE |
| K200803 | BEAR and BEAR miniNFO · Traditional | Foreo, Inc. | 07/31/2020SE |
| K191672 | NuFACE Mini DeviceNFO · Traditional | Carol Cole Company Dba Nuface | 10/15/2019SE |
| K190269 | PureLiftNFO · Traditional | Xtreem Pulse, LLC | 08/28/2019SE |
| K183189 | Ultra OTC Facial Toning SystemNFO · Traditional | Micro Current Technology, Inc. | 04/17/2019SE |
| K182424 | NuFACE FIX Skin Toning DeviceNFO · Traditional | Carol Cole Company Dba Nuface | 12/18/2018SE |
| K181008 | NuFACE TrinityNFO · Traditional | Carol Cole Company Dba Nuface | 10/11/2018SE |
| K181062 | Ultra Facial Toning SystemNFO · Traditional | Micro Current Technology, Inc. | 07/18/2018SE |
| K173093 | TAMA BEMS deviceNFO · Traditional | Tama Research Corporation | 06/05/2018SE |
| K171821 | 2 Face / Face EvolutionNFO · Traditional | Heat IN A Click | 04/26/2018SE |
| K163550 | Pobling MIITY 2NFO · Traditional | Habalan Med & Beauty Co.,Ltd | 12/20/2017SE |
| K162652 | Smart Photon Micro-current Device, Model: EP-300NFO · Traditional | Li-Tek Electronic Technology Corporation | 10/25/2017SE |
| K171647 | BeneLife Premium Facial Treatment Pack, Model: QZ0701ANFO · Traditional | Infinitus (China) Company , Ltd. | 10/23/2017SE |
| K171588 | NuBODY Skin Toning DeviceNFO · Traditional | Carol Cole Company Dba Nuface | 07/31/2017SE |
| K163470 | Galvanic Spa, Model: SKB-1405NFO · Traditional | Shenzhen Siken 3D Technology Development Co., Ltd. | 06/02/2017SE |
| K161484 | ZIIP DeviceNFO · Traditional | Ziip,Llc | 02/24/2017SE |
| K162106 | Micro-current Wrinkle Reduction Facial service, model EP-400NFO · Traditional | Li-Tek Electronic Technology Corporation | 02/03/2017SE |
| K152199 | RejuvatoneMDNFO · Traditional | Trophy Skin, Inc. | 03/23/2016SE |
| K150826 | Nutra Face Lift Model PE8050NFO · Traditional | Nutra Luxe MD, LLC | 02/10/2016SE |
| K150077 | SonicLiftNFO · Traditional | Pretika Corporation | 11/25/2015SE |
| K142794 | Everyway Facial MENSNFO · Traditional | Everyway Medical Instruments Co.,Ltd | 06/02/2015SE |
| K130065 | Beautiful Image Facial Sculpting DeviceNFO · Traditional | Biosonic Technologies, LLC | 04/30/2014SE |
| K133823 | Nuface Mini DeviceNFO · Abbreviated | Carol Cole Company | 04/17/2014SE |
| K131251 | Trinity EleNFO · Traditional | Carol Cole Company | 10/01/2013SE |
| K122711 | Facial SPANFO · Traditional | Nuskin | 09/17/2013SE |
| K120511 | Ageless Wonder Facial Muscle Stimulation SystemNFO · Traditional | Leto Enterprise , Ltd. | 07/30/2012SE |
| K112351 | Ultra BeautyNFO · Traditional | Johari Digital Healthcare , Ltd. | 03/30/2012SE |
| K113724 | Electropulse-CosmeticNFO · Traditional | Pain Relief Technologies | 02/15/2012SE |
| K102494 | The Buzz Facial Toning SystemNFO · Traditional | Daka International , Ltd. | 12/09/2011SE |
| K103031 | BMR FaceNFO · Traditional | Bio-Medical Research, Ltd. | 11/10/2011SE |
| K103472 | Nuface PlusNFO · Abbreviated | Carol Cole Company | 11/07/2011SE |
| K071573 | Rugalift, Model# V.2.1NFO · Abbreviated | Fatrotek S.R.L. | 12/09/2008SE |
| K070250 | Nutritone Facial Beauty SystemNFO · Traditional | Isomers Laboratories, Inc. | 09/04/2008SE |
| K070217 | Interx 1000/DERMA 200 Stimulator for Cosmetic UseNFO · Traditional | Neuro Resource Group, Inc. | 04/04/2008SE |
| K072260 | Nuface, Model NU-4003NFO · Traditional | Carol Cole Company | 11/27/2007SE |
| K040871 | Facemaster Facial Toning SystemNFO · Traditional | Facemaster of Beverly Hills, Inc. | 06/01/2005SE |
| K011935 | Rejuvenique Model #RJV10NFO · Traditional | Salton, Inc. | 08/08/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1140-2012 | iPico Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… | Ion Genius, Inc. | 01/06/2012Terminated |
| Z-1139-2012 | IELLIOS Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… | Ion Genius, Inc. | 01/06/2012Terminated |