PBX
- 产品代码
- PBX
- 器械名称
- Massager, Vacuum, Radio Frequency Induced Heat
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4400
- FDA 专业组
- General, Plastic Surgery
- 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)
- 18 件
- 其中 Summary 已存档
- 16 份,可直接下载
- FDA 历史累计 510(k)
- 79 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
该代码近三年的 510(k)(18 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253480 | 2026-07-10 | Capenergy Medical S.L. | Capenergy C Equipments RF C200 and C400 Drakarian | |
| K260647 | 2026-04-02 | El.En S.P.A. | SPECCHIO | |
| K253261 | 2026-03-13 | Weero Co., Ltd. | Apollo Quattro (APQ-10M) | |
| K252888 | 2026-03-09 | S&M Medical Co., Ltd. | NeoSculpt Plus | |
| K250734 | 2025-09-10 | Pollogen, Ltd. | OptiLUV Device | |
| K250916 | 2025-08-14 | Shenzhen Leaflife Technology Co., Ltd. | WinForth (LM-E470KA) | — |
| K243716 | 2025-05-28 | Termosalud S.L. | Zionic Pro Max (Radiofrequency) | |
| K241733 | 2025-04-16 | Novasonix Technology S.L. | HEBE (NP0000763) | |
| K243055 | 2025-04-15 | EMA Aesthetics , Ltd. | Préime DermaFacial Collagen+ | — |
| K242175 | 2025-02-27 | Xod, Inc. | XOD Diathermia Radiofrequency Device | |
| K241107 | 2025-01-24 | Indiba S. A. U. | Indiba Diathermia Radiofrequency Deep Care Device ( | |
| K232966 | 2024-12-26 | Golden Star Srl | FISIOWARM 7.0 | |
| K242553 | 2024-11-21 | General Vibronics, Inc. | MIRARI® Cold Plasma System ( GV-M2-01) | |
| K243164 | 2024-11-20 | Indiba S. A. U. | INDIBA COMPACT devices | |
| K242598 | 2024-11-14 | InMode , Ltd. | DEFINE System (AG612444A) | |
| K240991 | 2024-10-09 | Weero Co., Ltd. | eMVFit (MVF-10M) | |
| K240178 | 2024-07-15 | Zimmer Medizinsysteme GmbH | RFG-01 | |
| K230755 | 2023-10-30 | Bios S.R.L. | NuEra Tight RF Model OptiStream |
FDA 官方分类页: PBX
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。