NFO
- 产品代码
- NFO
- 器械名称
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.5890
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 79 件
该代码近三年的 510(k)（30 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253932 | 2026-07-23 | Shenzhen Kaiyan Medical Equipment Co., | FACEGYM Pro Device (HD-109) | |
| K260179 | 2026-06-03 | Touchbeauty Beauty & Health (Shenzhen) | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | |
| K260895 | 2026-05-28 | Guangxi Ulike Medical Technology Co., | Ulike Clear Zero (YC10 BU) | FDA |
| K252621 | 2026-05-08 | El Global Trade, Ltd. | DeepSkin (DEP100) | |
| K252187 | 2025-12-23 | Aura Medical, LLC | Aura Glide (FC40) | |
| K252146 | 2025-12-23 | Shenzhen Siken 3D Technology Developme | Multi-functional Facial Beauty Device ( SKB-1703,SKB | |
| K250618 | 2025-10-29 | Ya-Man, Ltd. | Medi Lift Essential Eye Mask | |
| K250227 | 2025-10-17 | Shenzhen Qianyu Technology Co., Ltd. | JOVS Electric Stimulation Beauty Device (JE2) | |
| K251034 | 2025-10-12 | Shenzhen Nuon Medical Equipment Co., L | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70 | FDA |
| K252553 | 2025-10-09 | Shenzhen Jianchao Intelligent Technolo | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, | |
| K251649 | 2025-09-18 | ShenB Co., Ltd. | Sunny Plus (Sunny) | |
| K251909 | 2025-09-03 | A-1 Engineering | NeurotriS (SX2500); NeurotriS (SX3800) | FDA |
| K252218 | 2025-07-18 | Micro Current Technology, Inc. | MF SC GEN2 Facial Toning System | — |
| K244004 | 2025-07-10 | Shenzhen Dachi Communication Co., Ltd. | Microcurrent Facial Device (CEC101, EE0101, EEI101) | |
| K250361 | 2025-05-23 | Geske Beauty Tech GmbH | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | |
| K243072 | 2025-04-01 | EMA Aesthetics , Ltd. | Préime DermaFacial (MicroT) | — |
| K243587 | 2025-03-06 | Xtreem Pulse, LLC | PureLift GLOW | |
| K243063 | 2025-02-10 | Raja Trading Company, Inc. | Myolight Microcurrent Handpiece | |
| K243393 | 2025-02-03 | Shenzhen Ulike Smart Electronics Co., | JMOON NouvelleSkin Facial Toning Device (M30U PR, M3 | |
| K244048 | 2025-01-16 | Ya-Man, Ltd. | Medi Lift Mask | |
| K243430 | 2024-12-19 | Shenzhen Aozemei Technology Co., Ltd. | Micro-current Facial Beauty Device (AM-810B, AM-810W | |
| K242532 | 2024-12-13 | BTL Industries, Inc. | BTL-785BNF-E | |
| K240564 | 2024-06-27 | Carol Cole Company Dba Nuface® | NuFACE® FIX+ | |
| K232242 | 2024-05-13 | Foreo, Inc. | BEAR 2 Body | — |
| K233667 | 2024-02-12 | Body Trim Industrial Co., Ltd. | Facial Toning device (UIC-189); Facial Toning device | |
| K233525 | 2023-11-24 | Micro Current Technology, Inc. | MF SC Facial Toning System | — |
| K233010 | 2023-11-21 | Belega, Inc. | Beagank 4T Plus | |
| K232001 | 2023-11-21 | Nse Products, Inc. | Nu Skin RenuSpa iO | FDA |
| K230459 | 2023-10-19 | 21 Equipment S.R.L. | C.C. Life 21 | — |
| K232172 | 2023-09-18 | BTL Industries, Inc. | BTL-785BNF Handpiece |
FDA 官方分类页： NFO
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。