Atlas FDA

NFO

79 FDA 510(k) clearances · Product code

172 daysmedian time to decision
437 days90th percentile
79clearances measured

FDA profile

Official device name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Medical specialty
Neurology
Flags
Third-party review eligible
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
FACEGYM Pro Device (HD-109) (K253932)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-07-23
VITA Multi-Function Head Brush (TB-2343F, TB-2442F) (K260179)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.2026-06-03
Ulike Clear Zero (YC10 BU) (K260895)Guangxi Ulike Medical Technology Co., Ltd.2026-05-28
DeepSkin (DEP100) (K252621)El Global Trade, Ltd.2026-05-08
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (K252146)Shenzhen Siken 3D Technology Development Co., Ltd.2025-12-23
Aura Glide (FC40) (K252187)Aura Medical, LLC2025-12-23
Medi Lift Essential Eye Mask (K250618)Ya-Man, Ltd.2025-10-29
JOVS Electric Stimulation Beauty Device (JE2) (K250227)Shenzhen Qianyu Technology Co., Ltd.2025-10-17
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) (K251034)Shenzhen Nuon Medical Equipment Co., Ltd.2025-10-12
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) (K252553)Shenzhen Jianchao Intelligent Technology Co., Ltd.2025-10-09
Sunny Plus (Sunny) (K251649)ShenB Co., Ltd.2025-09-18
NeurotriS (SX2500); NeurotriS (SX3800) (K251909)A-1 Engineering2025-09-03
MF SC GEN2 Facial Toning System (K252218)Micro Current Technology, Inc.2025-07-18
Microcurrent Facial Device (CEC101, EE0101, EEI101) (K244004)Shenzhen Dachi Communication Co., Ltd.2025-07-10
SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (K250361)Geske Beauty Tech GmbH2025-05-23
Préime DermaFacial (MicroT) (K243072)EMA Aesthetics , Ltd.2025-04-01
PureLift GLOW (K243587)Xtreem Pulse, LLC2025-03-06
Myolight Microcurrent Handpiece (K243063)Raja Trading Company, Inc.2025-02-10
JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) (K243393)Shenzhen Ulike Smart Electronics Co., Ltd.2025-02-03
Medi Lift Mask (K244048)Ya-Man, Ltd.2025-01-16
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K243430)Shenzhen Aozemei Technology Co., Ltd.2024-12-19
BTL-785BNF-E (K242532)BTL Industries, Inc.2024-12-13
NuFACE® FIX+ (K240564)Carol Cole Company Dba Nuface®2024-06-27
BEAR 2 Body (K232242)Foreo, Inc.2024-05-13
Facial Toning device (UIC-189); Facial Toning device (UIC-589) (K233667)Body Trim Industrial Co., Ltd.2024-02-12
MF SC Facial Toning System (K233525)Micro Current Technology, Inc.2023-11-24
Nu Skin RenuSpa iO (K232001)Nse Products, Inc.2023-11-21
Beagank 4T Plus (K233010)Belega, Inc.2023-11-21
C.C. Life 21 (K230459)21 Equipment S.R.L.2023-10-19
BTL-785BNF Handpiece (K232172)BTL Industries, Inc.2023-09-18
Medi Lift PLUS (K220198)Ya-Man, Ltd.2023-06-28
PureLift Pro Edition (K230506)Xtreem Pulse2023-06-21
Myolift QT (K213078)Johari Digital Healthcare Limited2023-04-27
PureLift Pro Plus (K221443)Xtreem Pulse, LLC2022-10-21
Luminice (K214100)Premier North America, Inc.2022-02-24
Microcurrent device (Model: HBR2-1) (K211055)Shenzhen DJ Medical Equipment Co., Ltd.2021-11-05
TheraFace Microcurrent (K212238)Theragun, Inc.2021-09-29
ZIIP+ Device (K212342)Ziip, Inc.2021-09-23
Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device (K191951)Avazzia, Inc.2021-04-27
Trinity ELE Plus and Trinity ELE Plus Pro (K201906)Carol Cole Company Dba Nuface2021-02-24
NuFACE Mini Plus (K201680)Carole Cole Company2021-02-19
NuFace Trinity Plus Device (K201782)Carol Cole Company Dba Nuface2021-01-22
Tua Face Fitness / Tua Trend Face (K192077)Vupiesse S.R.L2020-09-30
BEAR and BEAR mini (K200803)Foreo, Inc.2020-07-31
NuFACE Mini Device (K191672)Carol Cole Company Dba Nuface2019-10-15
PureLift (K190269)Xtreem Pulse, LLC2019-08-28
Ultra OTC Facial Toning System (K183189)Micro Current Technology, Inc.2019-04-17
NuFACE FIX Skin Toning Device (K182424)Carol Cole Company Dba Nuface2018-12-18
NuFACE Trinity (K181008)Carol Cole Company Dba Nuface2018-10-11
Ultra Facial Toning System (K181062)Micro Current Technology, Inc.2018-07-18
TAMA BEMS device (K173093)Tama Research Corporation2018-06-05
2 Face / Face Evolution (K171821)Heat IN A Click2018-04-26
Pobling MIITY 2 (K163550)Habalan Med & Beauty Co.,Ltd2017-12-20
Smart Photon Micro-current Device, Model: EP-300 (K162652)Li-Tek Electronic Technology Corporation2017-10-25
BeneLife Premium Facial Treatment Pack, Model: QZ0701A (K171647)Infinitus (China) Company , Ltd.2017-10-23
NuBODY Skin Toning Device (K171588)Carol Cole Company Dba Nuface2017-07-31
Galvanic Spa, Model: SKB-1405 (K163470)Shenzhen Siken 3D Technology Development Co., Ltd.2017-06-02
ZIIP Device (K161484)Ziip,Llc2017-02-24
Micro-current Wrinkle Reduction Facial service, model EP-400 (K162106)Li-Tek Electronic Technology Corporation2017-02-03
RejuvatoneMD (K152199)Trophy Skin, Inc.2016-03-23
Nutra Face Lift Model PE8050 (K150826)Nutra Luxe MD, LLC2016-02-10
SonicLift (K150077)Pretika Corporation2015-11-25
Everyway Facial MENS (K142794)Everyway Medical Instruments Co.,Ltd2015-06-02
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE (K130065)Biosonic Technologies, LLC2014-04-30
NUFACE MINI DEVICE (K133823)Carol Cole Company2014-04-17
TRINITY ELE (K131251)Carol Cole Company2013-10-01
FACIAL SPA (K122711)Nuskin2013-09-17
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM (K120511)Leto Enterprise , Ltd.2012-07-30
ULTRA BEAUTY (K112351)Johari Digital Healthcare , Ltd.2012-03-30
ELECTROPULSE-COSMETIC (K113724)Pain Relief Technologies2012-02-15
THE BUZZ FACIAL TONING SYSTEM (K102494)Daka International , Ltd.2011-12-09
BMR FACE (K103031)Bio-Medical Research, Ltd.2011-11-10
NUFACE PLUS (K103472)Carol Cole Company2011-11-07
RUGALIFT, MODEL# V.2.1 (K071573)Fatrotek S.R.L.2008-12-09
NUTRITONE FACIAL BEAUTY SYSTEM (K070250)Isomers Laboratories, Inc.2008-09-04
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE (K070217)Neuro Resource Group, Inc.2008-04-04
NUFACE, MODEL NU-4003 (K072260)Carol Cole Company2007-11-27
FACEMASTER FACIAL TONING SYSTEM (K040871)Facemaster of Beverly Hills, Inc.2005-06-01
REJUVENIQUE MODEL #RJV10 (K011935)Salton, Inc.2001-08-08

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Every clearance here is in the API, with alerts when new ones post.