FDA Product Code
FDA Product Code NFO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5890
510(k) Clearances — 82 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | 2026-09-16 | Traditional | PDF ↗ |
| K262861 | PureLift Pro Max | Xtreem Pulse, LLC | 2026-09-11 | Special | PDF ↗ |
| K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | Hironic Co., Ltd. | 2026-08-31 | Traditional | PDF ↗ |
| K253932 | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-07-23 | Traditional | PDF ↗ |
| K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2026-06-03 | Traditional | PDF ↗ |
| K260895 | Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. | 2026-05-28 | Traditional | PDF ↗ |
| K252621 | DeepSkin (DEP100) | El Global Trade, Ltd. | 2026-05-08 | Traditional | PDF ↗ |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-23 | Traditional | PDF ↗ |
| K252187 | Aura Glide (FC40) | Aura Medical, LLC | 2025-12-23 | Traditional | PDF ↗ |
| K250618 | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | 2025-10-29 | Traditional | PDF ↗ |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | 2025-10-17 | Traditional | PDF ↗ |
| K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025-10-12 | Traditional | PDF ↗ |
| 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) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2025-10-09 | Traditional | PDF ↗ |
| K251649 | Sunny Plus (Sunny) | ShenB Co., Ltd. | 2025-09-18 | Traditional | PDF ↗ |
| K251909 | NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering | 2025-09-03 | Traditional | PDF ↗ |
| K252218 | MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. | 2025-07-18 | Special | PDF ↗ |
| K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | 2025-07-10 | Traditional | PDF ↗ |
| K250361 | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech GmbH | 2025-05-23 | Traditional | PDF ↗ |
| K243072 | Préime DermaFacial (MicroT) | EMA Aesthetics , Ltd. | 2025-04-01 | Traditional | PDF ↗ |
| K243587 | PureLift GLOW | Xtreem Pulse, LLC | 2025-03-06 | Traditional | PDF ↗ |
| K243063 | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | 2025-02-10 | Traditional | PDF ↗ |
| K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-02-03 | Traditional | PDF ↗ |
| K244048 | Medi Lift Mask | Ya-Man, Ltd. | 2025-01-16 | Special | PDF ↗ |
| K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024-12-19 | Traditional | PDF ↗ |
| K242532 | BTL-785BNF-E | BTL Industries, Inc. | 2024-12-13 | Traditional | PDF ↗ |
| K240564 | NuFACE® FIX+ | Carol Cole Company Dba Nuface® | 2024-06-27 | Traditional | PDF ↗ |
| K232242 | BEAR 2 Body | Foreo, Inc. | 2024-05-13 | Traditional | PDF ↗ |
| K233667 | Facial Toning device (UIC-189); Facial Toning device (UIC-589) | Body Trim Industrial Co., Ltd. | 2024-02-12 | Traditional | PDF ↗ |
| K233525 | MF SC Facial Toning System | Micro Current Technology, Inc. | 2023-11-24 | Traditional | PDF ↗ |
| K233010 | Beagank 4T Plus | Belega, Inc. | 2023-11-21 | Traditional | PDF ↗ |
| K232001 | Nu Skin RenuSpa iO | Nse Products, Inc. | 2023-11-21 | Traditional | PDF ↗ |
| K230459 | C.C. Life 21 | 21 Equipment S.R.L. | 2023-10-19 | Traditional | PDF ↗ |
| K232172 | BTL-785BNF Handpiece | BTL Industries, Inc. | 2023-09-18 | Traditional | PDF ↗ |
| K220198 | Medi Lift PLUS | Ya-Man, Ltd. | 2023-06-28 | Traditional | PDF ↗ |
| K230506 | PureLift Pro Edition | Xtreem Pulse | 2023-06-21 | Special | PDF ↗ |
| K213078 | Myolift QT | Johari Digital Healthcare Limited | 2023-04-27 | Traditional | PDF ↗ |
| K221443 | PureLift Pro Plus | Xtreem Pulse, LLC | 2022-10-21 | Special | PDF ↗ |
| K214100 | Luminice | Premier North America, Inc. | 2022-02-24 | Traditional | PDF ↗ |
| K211055 | Microcurrent device (Model: HBR2-1) | Shenzhen DJ Medical Equipment Co., Ltd. | 2021-11-05 | Traditional | PDF ↗ |
| K212238 | TheraFace Microcurrent | Theragun, Inc. | 2021-09-29 | Traditional | PDF ↗ |
| K212342 | ZIIP+ Device | Ziip, Inc. | 2021-09-23 | Traditional | PDF ↗ |
| K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device | Avazzia, Inc. | 2021-04-27 | Traditional | PDF ↗ |
| K201906 | Trinity ELE Plus and Trinity ELE Plus Pro | Carol Cole Company Dba Nuface | 2021-02-24 | Traditional | PDF ↗ |
| K201680 | NuFACE Mini Plus | Carole Cole Company | 2021-02-19 | Abbreviated | PDF ↗ |
| K201782 | NuFace Trinity Plus Device | Carol Cole Company Dba Nuface | 2021-01-22 | Traditional | PDF ↗ |
| K192077 | Tua Face Fitness / Tua Trend Face | Vupiesse S.R.L | 2020-09-30 | Traditional | PDF ↗ |
| K200803 | BEAR and BEAR mini | Foreo, Inc. | 2020-07-31 | Traditional | PDF ↗ |
| K191672 | NuFACE Mini Device | Carol Cole Company Dba Nuface | 2019-10-15 | Traditional | PDF ↗ |
| K190269 | PureLift | Xtreem Pulse, LLC | 2019-08-28 | Traditional | PDF ↗ |
| K183189 | Ultra OTC Facial Toning System | Micro Current Technology, Inc. | 2019-04-17 | Traditional | PDF ↗ |
| K182424 | NuFACE FIX Skin Toning Device | Carol Cole Company Dba Nuface | 2018-12-18 | Traditional | PDF ↗ |
| K181008 | NuFACE Trinity | Carol Cole Company Dba Nuface | 2018-10-11 | Traditional | PDF ↗ |
| K181062 | Ultra Facial Toning System | Micro Current Technology, Inc. | 2018-07-18 | Traditional | PDF ↗ |
| K173093 | TAMA BEMS device | Tama Research Corporation | 2018-06-05 | Traditional | PDF ↗ |
| K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018-04-26 | Traditional | PDF ↗ |
| K163550 | Pobling MIITY 2 | Habalan Med & Beauty Co.,Ltd | 2017-12-20 | Traditional | PDF ↗ |
| K162652 | Smart Photon Micro-current Device, Model: EP-300 | Li-Tek Electronic Technology Corporation | 2017-10-25 | Traditional | PDF ↗ |
| K171647 | BeneLife Premium Facial Treatment Pack, Model: QZ0701A | Infinitus (China) Company , Ltd. | 2017-10-23 | Traditional | PDF ↗ |
| K171588 | NuBODY Skin Toning Device | Carol Cole Company Dba Nuface | 2017-07-31 | Traditional | PDF ↗ |
| K163470 | Galvanic Spa, Model: SKB-1405 | Shenzhen Siken 3D Technology Development Co., Ltd. | 2017-06-02 | Traditional | PDF ↗ |
| K161484 | ZIIP Device | Ziip,Llc | 2017-02-24 | Traditional | PDF ↗ |
| K162106 | Micro-current Wrinkle Reduction Facial service, model EP-400 | Li-Tek Electronic Technology Corporation | 2017-02-03 | Traditional | PDF ↗ |
| K152199 | RejuvatoneMD | Trophy Skin, Inc. | 2016-03-23 | Traditional | PDF ↗ |
| K150826 | Nutra Face Lift Model PE8050 | Nutra Luxe MD, LLC | 2016-02-10 | Traditional | PDF ↗ |
| K150077 | SonicLift | Pretika Corporation | 2015-11-25 | Traditional | PDF ↗ |
| K142794 | Everyway Facial MENS | Everyway Medical Instruments Co.,Ltd | 2015-06-02 | Traditional | PDF ↗ |
| K130065 | BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE | Biosonic Technologies, LLC | 2014-04-30 | Traditional | PDF ↗ |
| K133823 | NUFACE MINI DEVICE | Carol Cole Company | 2014-04-17 | Abbreviated | PDF ↗ |
| K131251 | TRINITY ELE | Carol Cole Company | 2013-10-01 | Traditional | PDF ↗ |
| K122711 | FACIAL SPA | Nuskin | 2013-09-17 | Traditional | PDF ↗ |
| K120511 | AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM | Leto Enterprise , Ltd. | 2012-07-30 | Traditional | PDF ↗ |
| K112351 | ULTRA BEAUTY | Johari Digital Healthcare , Ltd. | 2012-03-30 | Traditional | PDF ↗ |
| K113724 | ELECTROPULSE-COSMETIC | Pain Relief Technologies | 2012-02-15 | Traditional | PDF ↗ |
| K102494 | THE BUZZ FACIAL TONING SYSTEM | Daka International , Ltd. | 2011-12-09 | Traditional | PDF ↗ |
| K103031 | BMR FACE | Bio-Medical Research, Ltd. | 2011-11-10 | Traditional | PDF ↗ |
| K103472 | NUFACE PLUS | Carol Cole Company | 2011-11-07 | Abbreviated | PDF ↗ |
| K071573 | RUGALIFT, MODEL# V.2.1 | Fatrotek S.R.L. | 2008-12-09 | Abbreviated | PDF ↗ |
| K070250 | NUTRITONE FACIAL BEAUTY SYSTEM | Isomers Laboratories, Inc. | 2008-09-04 | Traditional | PDF ↗ |
| K070217 | INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE | Neuro Resource Group, Inc. | 2008-04-04 | Traditional | PDF ↗ |
| K072260 | NUFACE, MODEL NU-4003 | Carol Cole Company | 2007-11-27 | Traditional | PDF ↗ |
| K040871 | FACEMASTER FACIAL TONING SYSTEM | Facemaster of Beverly Hills, Inc. | 2005-06-01 | Traditional | PDF ↗ |
| K011935 | REJUVENIQUE MODEL #RJV10 | Salton, Inc. | 2001-08-08 | Traditional | PDF ↗ |
Product code NFO · Class II · Neurology. Data: openFDA.