Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → PBX — Massager, Vacuum, Radio Frequency Induced Heat # PBX · Massager, Vacuum, Radio Frequency Induced Heat _General, Plastic Surgery · 21 CFR 878.4400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX ## Overview - **Product Code:** PBX - **Device Name:** Massager, Vacuum, Radio Frequency Induced Heat - **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K260647.md) | SPECCHIO | El.En S.P.A. | Apr 2, 2026 | SESE | | [K253261](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K253261.md) | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | Mar 13, 2026 | SESE | | [K252888](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K252888.md) | NeoSculpt Plus | S&M Medical Co., Ltd. | Mar 9, 2026 | SESE | | [K250734](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K250734.md) | OptiLUV Device | Pollogen, Ltd. | Sep 10, 2025 | SESE | | [K250916](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K250916.md) | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. | Aug 14, 2025 | SESE | | [K243716](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K243716.md) | Zionic Pro Max (Radiofrequency) | Termosalud S.L. | May 28, 2025 | SESE | | [K241733](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K241733.md) | HEBE (NP0000763) | Novasonix Technology S.L. | Apr 16, 2025 | SESE | | [K243055](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K243055.md) | Préime DermaFacial Collagen+ | EMA Aesthetics , Ltd. | Apr 15, 2025 | SESE | | [K242175](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K242175.md) | XOD Diathermia Radiofrequency Device | Xod, Inc. | Feb 27, 2025 | SESE | | [K241107](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K241107.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K232966.md) | FISIOWARM 7.0 | Golden Star Srl | Dec 26, 2024 | SESE | | [K242553](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K242553.md) | MIRARI® Cold Plasma System ( GV-M2-01) | General Vibronics, Inc. | Nov 21, 2024 | SESE | | [K243164](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K243164.md) | INDIBA COMPACT devices | Indiba S. A. U. | Nov 20, 2024 | SESE | | [K242598](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K242598.md) | DEFINE System (AG612444A) | InMode , Ltd. | Nov 14, 2024 | SESE | | [K240991](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K240991.md) | eMVFit (MVF-10M) | Weero Co., Ltd. | Oct 9, 2024 | SESE | | [K240178](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K240178.md) | RFG-01 | Zimmer Medizinsysteme GmbH | Jul 15, 2024 | SESE | | [K230755](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K230755.md) | NuEra Tight RF Model OptiStream | Bios S.R.L. | Oct 30, 2023 | SESE | | [K230037](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K230037.md) | BACK 3 | Swims America Corp | Jul 19, 2023 | SESE | | [K230659](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K230659.md) | Zionic Aesthetic | Termosalud | Jun 8, 2023 | SESE | | [K213256](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K213256.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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