Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation 882.5890
10510(k)s in 12 months (83 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in NFO
| Company | 510(k)s | Recalls |
|---|---|---|
| Carol Cole Company Dba Nuface | 7 | 0 |
| Xtreem Pulse | 5 | 0 |
| Carol Cole Company | 4 | 0 |
| Micro Current Technology, Inc. | 4 | 0 |
| Foreo, Inc. | 3 | 0 |
| Ya-Man, Ltd. | 3 | 0 |
| BTL Industries, Inc. | 2 | 0 |
| Ion Genius, Inc. | 0 | 2 |
| Johari Digital Healthcare , Ltd. | 2 | 0 |
| Li-Tek Electronic Technology Corporation | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2026 | K261565 | FAQ (FAQ 411) Foreo, Inc. | NFO |
| Sep 16, 2026 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) Guangdong Newdermo Biotech Co., Ltd., CN | NFO |
| Sep 11, 2026 | K262861 | PureLift Pro Max Xtreem Pulse, LLC | NFO |
| Aug 31, 2026 | K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) Hironic Co., Ltd., CN | NFO |
| Jul 23, 2026 | K253932 | FACEGYM Pro Device (HD-109) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | NFO |
| Jun 3, 2026 | K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) Touchbeauty Beauty & Health (Shenzhen) Co., Ltd., CN | NFO |
| May 28, 2026 | K260895 | Ulike Clear Zero (YC10 BU) Guangxi Ulike Medical Technology Co., Ltd., CN | NFO |
| May 8, 2026 | K252621 | DeepSkin (DEP100) El Global Trade, Ltd., IL | NFO |
| Dec 23, 2025 | K252187 | Aura Glide (FC40) Aura Medical, LLC | NFO |
| 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) Shenzhen Siken 3D Technology Development Co., Ltd., CN | NFO |
| Oct 29, 2025 | K250618 | Medi Lift Essential Eye Mask Ya-Man, Ltd., JP | NFO |
| Oct 17, 2025 | K250227 | JOVS Electric Stimulation Beauty Device (JE2) Shenzhen Qianyu Technology Co., Ltd., CN | NFO |
| Oct 12, 2025 | K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) Shenzhen Nuon Medical Equipment Co., Ltd., CN | NFO |
| Oct 9, 2025 | K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, Shenzhen Jianchao Intelligent Technology Co., Ltd., CN | NFO |
| Sep 18, 2025 | K251649 | Sunny Plus (Sunny) ShenB Co., Ltd., KR | NFO |
| Sep 3, 2025 | K251909 | NeurotriS (SX2500); NeurotriS (SX3800) A-1 Engineering | NFO |
| Jul 18, 2025 | K252218 | MF SC GEN2 Facial Toning System Micro Current Technology, Inc. | NFO |
| Jul 10, 2025 | K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101) Shenzhen Dachi Communication Co., Ltd., CN | NFO |
| May 23, 2025 | K250361 | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 Geske Beauty Tech GmbH, DE | NFO |
| Apr 1, 2025 | K243072 | Préime DermaFacial (MicroT) EMA Aesthetics , Ltd., IE | NFO |
| Mar 6, 2025 | K243587 | PureLift GLOW Xtreem Pulse, LLC | NFO |
| Feb 10, 2025 | K243063 | Myolight Microcurrent Handpiece Raja Trading Company, Inc. | NFO |
| Feb 3, 2025 | K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) Shenzhen Ulike Smart Electronics Co., Ltd., CN | NFO |
| Jan 16, 2025 | K244048 | Medi Lift Mask Ya-Man, Ltd., JP | NFO |
| Dec 19, 2024 | K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) Shenzhen Aozemei Technology Co., Ltd., CN | NFO |
| Dec 13, 2024 | K242532 | BTL-785BNF-E BTL Industries, Inc. | NFO |
| Jun 27, 2024 | K240564 | NuFACE® FIX+ Carol Cole Company Dba Nuface® | NFO |
| May 13, 2024 | K232242 | BEAR 2 Body Foreo, Inc. | NFO |
| Feb 12, 2024 | K233667 | Facial Toning device (UIC-189); Facial Toning device (UIC-589) Body Trim Industrial Co., Ltd., TW | NFO |
| Nov 24, 2023 | K233525 | MF SC Facial Toning System Micro Current Technology, Inc. | NFO |
| Nov 21, 2023 | K233010 | Beagank 4T Plus Belega, Inc., JP | NFO |
| Nov 21, 2023 | K232001 | Nu Skin RenuSpa iO Nse Products, Inc. | NFO |
| Oct 19, 2023 | K230459 | C.C. Life 21 21 Equipment S.R.L., IT | NFO |
| Sep 18, 2023 | K232172 | BTL-785BNF Handpiece BTL Industries, Inc. | NFO |
| Jun 28, 2023 | K220198 | Medi Lift PLUS Ya-Man, Ltd., JP | NFO |
| Jun 21, 2023 | K230506 | PureLift Pro Edition Xtreem Pulse | NFO |
| Apr 27, 2023 | K213078 | Myolift QT Johari Digital Healthcare Limited, IN | NFO |
| Oct 21, 2022 | K221443 | PureLift Pro Plus Xtreem Pulse, LLC | NFO |
| Feb 24, 2022 | K214100 | Luminice Premier North America, Inc. | NFO |
| Nov 5, 2021 | K211055 | Microcurrent device (Model: HBR2-1) Shenzhen DJ Medical Equipment Co., Ltd., CN | NFO |
| Sep 29, 2021 | K212238 | TheraFace Microcurrent Theragun, Inc. | NFO |
| Sep 23, 2021 | K212342 | ZIIP+ Device Ziip, Inc. | NFO |
| Apr 27, 2021 | K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device Avazzia, Inc. | NFO |
| Feb 24, 2021 | K201906 | Trinity ELE Plus and Trinity ELE Plus Pro Carol Cole Company Dba Nuface | NFO |
| Feb 19, 2021 | K201680 | NuFACE Mini Plus Carole Cole Company | NFO |
| Jan 22, 2021 | K201782 | NuFace Trinity Plus Device Carol Cole Company Dba Nuface | NFO |
| Sep 30, 2020 | K192077 | Tua Face Fitness / Tua Trend Face Vupiesse S.R.L, IT | NFO |
| Jul 31, 2020 | K200803 | BEAR and BEAR mini Foreo, Inc. | NFO |
| Oct 15, 2019 | K191672 | NuFACE Mini Device Carol Cole Company Dba Nuface | NFO |
| Aug 28, 2019 | K190269 | PureLift Xtreem Pulse, LLC | NFO |
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