Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Neurology · 21 CFR 882.5890
Recent MDR events
37 adverse event reports on file
- NUFACE TRINITYJun 25, 2026InjuryCarol Cole Company Dba NufaceMW5189897
- NUFACE TRINITY PLUS FACIAL AND NECK TONING DEVICESep 29, 2025InjuryCarol Cole Company Dba NufaceMW5176749
- MEDICUBE AGE-R BOOSTER PROAug 11, 2025InjuryApr Co., LtdMW5174314
- NU SKIN FACIAL SPAJun 16, 2025InjuryNse Products, Inc.3001236514-2025-00001
- NUFACE MINI+May 8, 2025InjuryCarol Cole CompanyMW5170116
- NUFACEAug 27, 2024InjuryCarol Cole CompanyMW5158932
- BEAR 2 MICRO CURRENTMay 21, 2024InjuryForeo, Inc.MW5155226
- NUFACE TRINITY+Apr 11, 2024InjuryNuface By Carol Cole / Carol Cole CompanyMW5153785
- NUFACE MICROCURRENTFeb 23, 2024InjuryCarol Cole CompanyMW5152002
- NUFACEJun 6, 2023InjuryCarol Cole CompanyMW5118233
Event type breakdown
Recalls
2 recall events for this product code
- Ion Genius, Inc.TerminatedMar 1, 2012
IELLIOS
Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
Z-1139-2012 · View FDA record ↗ - Ion Genius, Inc.TerminatedMar 1, 2012
iPico
Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
Z-1140-2012 · View FDA record ↗
Registered firms
101 firms currently registered for this product code
Key Tronic Juarez, S.a De C.v.
Juarez Chihuahua, MX
Emage Medical, Llc
Charlotte, NC, US
Carol Cole Company Dba Nuface
Vista, CA, US
Biosonic Technologies, Llc
Las Vegas, NV, US
Longcheer Meiko Electronics Vietnam Company Limited
Hanoi Ha Noi, VN
Avazzia, Inc.
DALLAS, TX, US
Micro Current Technology, Inc.
SEATTLE, WA, US
Shenzhen Ulike Smart Electronics Co.,ltd
Shenzhen Guangdong, CN
Shenzhen Zowee Smart Manufacturing Co., Ltd.
Shenzhen Guangdong, CN
Shenzhen Siken 3d Technology Development Co., Ltd.
Dongguan Guangdong, CN
Foreo Inc
Las Vegas, NV, US
Syrma Johari Medtech Limited
Jodhpur Rajasthan, IN
Shenzhen Jianchao Intelligent Technology Co., Ltd.
Shenzhen Guangdong, CN
Ya-man Ltd.
Koto-ku Tokyo, JP
Shenzhen Qianyu Technology Co., Ltd.
Shenzhen Guangdong, CN
Vis (shanghai) Technology Co., Ltd.
Jinshan District Shanghai, CN
Luna X Inc
Sioux Falls, SD, US
Rosti Integrated Manufacturing Solutions (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
510(k) clearances
79 clearances for this product code
- Shenzhen Kaiyan Medical Equipment Co., Ltd.Jul 23, 2026
K253932 · FACEGYM Pro Device (HD-109)
- Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.Jun 3, 2026
K260179 · VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
- Guangxi Ulike Medical Technology Co., Ltd.May 28, 2026
K260895 · Ulike Clear Zero (YC10 BU)
- El Global Trade, Ltd.May 8, 2026
K252621 · DeepSkin (DEP100)
- Shenzhen Siken 3D Technology Development Co., Ltd.Dec 23, 2025
K252146 · Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
- Aura Medical, LLCDec 23, 2025
K252187 · Aura Glide (FC40)
- Ya-Man, Ltd.Oct 29, 2025
K250618 · Medi Lift Essential Eye Mask
- Shenzhen Qianyu Technology Co., Ltd.Oct 17, 2025
K250227 · JOVS Electric Stimulation Beauty Device (JE2)