FDA 510(k) Applications for Medical Device Product Code "NFO"
(Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K191951 | Avazzia, Inc | Avazzia OTC TENS for aesthetics, model BEST-AV1Ö: EZZI-LIFTÖ Device | 04/27/2021 |
| K103031 | BIO-MEDICAL RESEARCH, LTD. | BMR FACE | 11/10/2011 |
| K130065 | BIOSONIC TECHNOLOGIES, LLC | BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE | 04/30/2014 |
| K232172 | BTL Industries Inc. | BTL-785BNF Handpiece | 09/18/2023 |
| K133823 | Carol Cole Company | NUFACE MINI DEVICE | 04/17/2014 |
| K103472 | Carol Cole Company | NUFACE PLUS | 11/07/2011 |
| K072260 | Carol Cole Company | NUFACE, MODEL NU-4003 | 11/27/2007 |
| K131251 | Carol Cole Company | TRINITY ELE | 10/01/2013 |
| K171588 | Carol Cole Company dba NuFACE | NuBODY Skin Toning Device | 07/31/2017 |
| K182424 | Carol Cole Company dba NuFACE | NuFACE FIX Skin Toning Device | 12/18/2018 |
| K191672 | Carol Cole Company dba NuFACE | NuFACE Mini Device | 10/15/2019 |
| K181008 | Carol Cole Company dba NuFACE | NuFACE Trinity | 10/11/2018 |
| K201782 | Carol Cole Company dba NuFACE | NuFace Trinity Plus Device | 01/22/2021 |
| K201906 | Carol Cole Company dba NuFACE | Trinity ELE Plus and Trinity ELE Plus Pro | 02/24/2021 |
| K201680 | Carole Cole Company | NuFACE Mini Plus | 02/19/2021 |
| K102494 | DAKA INTERNATIONAL LTD. | THE BUZZ FACIAL TONING SYSTEM | 12/09/2011 |
| K142794 | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | Everyway Facial MENS | 06/02/2015 |
| K040871 | FACEMASTER OF BEVERLY HILLS, INC. | FACEMASTER FACIAL TONING SYSTEM | 06/01/2005 |
| K071573 | FATROTEK S.R.L. | RUGALIFT, MODEL# V.2.1 | 12/09/2008 |
| K200803 | FOREO, Inc. | BEAR and BEAR mini | 07/31/2020 |
| K163550 | HABALAN MED & BEAUTY CO.,LTD | Pobling MIITY 2 | 12/20/2017 |
| K171821 | Heat In A Click | 2 Face / Face Evolution | 04/26/2018 |
| K171647 | Infinitus (China) Company Ltd. | BeneLife Premium Facial Treatment Pack, Model: QZ0701A | 10/23/2017 |
| K070250 | ISOMERS LABORATORIES INC. | NUTRITONE FACIAL BEAUTY SYSTEM | 09/04/2008 |
| K213078 | Johari Digital Healthcare Limited | Myolift QT | 04/27/2023 |
| K112351 | JOHARI DIGITAL HEALTHCARE, LTD. | ULTRA BEAUTY | 03/30/2012 |
| K120511 | LETO ENTERPRISE LTD. | AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM | 07/30/2012 |
| K162106 | Li-Tek Electronic Technology Corporation | Micro-current Wrinkle Reduction Facial service, model EP-400 | 02/03/2017 |
| K162652 | LI-TEK ELECTRONIC TECHNOLOGY CORPORATION | Smart Photon Micro-current Device, Model: EP-300 | 10/25/2017 |
| K181062 | Micro Current Technology, Inc. | Ultra Facial Toning System | 07/18/2018 |
| K183189 | Micro Current Technology, Inc. | Ultra OTC Facial Toning System | 04/17/2019 |
| K070217 | NEURO RESOURCE GROUP, INC. | INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE | 04/04/2008 |
| K122711 | NUSKIN | FACIAL SPA | 09/17/2013 |
| K150826 | NUTRA LUXE MD, LLC | Nutra Face Lift Model PE8050 | 02/10/2016 |
| K113724 | PAIN RELIEF TECHNOLOGIES | ELECTROPULSE-COSMETIC | 02/15/2012 |
| K214100 | Premier North America Inc. | Luminice | 02/24/2022 |
| K150077 | PRETIKA CORPORATION | SonicLift | 11/25/2015 |
| K011935 | SALTON, INC. | REJUVENIQUE MODEL #RJV10 | 08/08/2001 |
| K211055 | Shenzhen DJ Medical Equipment Co., Ltd. | Microcurrent device (Model: HBR2-1) | 11/05/2021 |
| K163470 | ShenZhen Siken 3D Technology Development Co., Ltd. | Galvanic Spa, Model: SKB-1405 | 06/02/2017 |
| K173093 | TAMA Research Corporation | TAMA BEMS device | 06/05/2018 |
| K212238 | Theragun, Inc. | TheraFace Microcurrent | 09/29/2021 |
| K152199 | TROPHY SKIN, INC. | RejuvatoneMD | 03/23/2016 |
| K192077 | Vupiesse S.R.L | Tua Face Fitness / Tua Trend Face | 09/30/2020 |
| K230506 | Xtreem Pulse | PureLift Pro Edition | 06/21/2023 |
| K221443 | Xtreem Pulse LLC | PureLift Pro Plus | 10/21/2022 |
| K190269 | Xtreem Pulse, LLC | PureLift | 08/28/2019 |
| K220198 | YA-MAN Ltd | Medi Lift PLUS | 06/28/2023 |
| K212342 | ZIIP, Inc | ZIIP+ Device | 09/23/2021 |
| K161484 | ZIIP,LLC | ZIIP Device | 02/24/2017 |
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