PBX
- Product code
- PBX
- Device name
- Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 79
FDA classification definition
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.
510(k) clearances, last 3 years (18)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| 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 |
Official FDA classification page: PBX
Classification and pathway per current FDA publications. Data from openFDA (CC0).