PBX · Massager, Vacuum, Radio Frequency Induced Heat
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | PBX |
|---|---|
| Device Name | Massager, Vacuum, Radio Frequency Induced Heat |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 78)
Showing 20 most recent of 78 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260647 | SPECCHIO | El.En S.P.A. | Apr 2, 2026 | SESE |
| K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | Mar 13, 2026 | SESE |
| K252888 | NeoSculpt Plus | S&M Medical Co., Ltd. | Mar 9, 2026 | SESE |
| K250734 | OptiLUV Device | Pollogen, Ltd. | Sep 10, 2025 | SESE |
| K250916 | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. | Aug 14, 2025 | SESE |
| K243716 | Zionic Pro Max (Radiofrequency) | Termosalud S.L. | May 28, 2025 | SESE |
| K241733 | HEBE (NP0000763) | Novasonix Technology S.L. | Apr 16, 2025 | SESE |
| K243055 | Préime DermaFacial Collagen+ | EMA Aesthetics , Ltd. | Apr 15, 2025 | SESE |
| K242175 | XOD Diathermia Radiofrequency Device | Xod, Inc. | Feb 27, 2025 | SESE |
| K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) | Indiba S. A. U. | Jan 24, 2025 | SESE |
| K232966 | FISIOWARM 7.0 | Golden Star Srl | Dec 26, 2024 | SESE |
| K242553 | MIRARI® Cold Plasma System ( GV-M2-01) | General Vibronics, Inc. | Nov 21, 2024 | SESE |
| K243164 | INDIBA COMPACT devices | Indiba S. A. U. | Nov 20, 2024 | SESE |
| K242598 | DEFINE System (AG612444A) | InMode , Ltd. | Nov 14, 2024 | SESE |
| K240991 | eMVFit (MVF-10M) | Weero Co., Ltd. | Oct 9, 2024 | SESE |
| K240178 | RFG-01 | Zimmer Medizinsysteme GmbH | Jul 15, 2024 | SESE |
| K230755 | NuEra Tight RF Model OptiStream | Bios S.R.L. | Oct 30, 2023 | SESE |
| K230037 | BACK 3 | Swims America Corp | Jul 19, 2023 | SESE |
| K230659 | Zionic Aesthetic | Termosalud | Jun 8, 2023 | SESE |
| K213256 | ThermoTK | Zimmer Medizinsysteme GmbH | May 25, 2023 | SESE |
Top Applicants
- Venus Concept USA, Inc. — 5 clearances
- Inmode MD , Ltd. — 5 clearances
- Cutera, Inc. — 5 clearances
- Bios S.R.L. — 5 clearances
- BTL Industries, Inc. — 5 clearances
