PBX — Massager, Vacuum, Radio Frequency Induced Heat Class II
Classification Details
- Product Code
- PBX
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253261 | weero co | Apollo Quattro (APQ-10M) | March 13, 2026 |
| K252888 | s and m medical co | NeoSculpt Plus | March 9, 2026 |
| K250734 | pollogen | OptiLUV Device | September 10, 2025 |
| K250916 | shenzhen leaflife technology co | WinForth (LM-E470KA) | August 14, 2025 |
| K243716 | termosalud s.l | Zionic Pro Max (Radiofrequency) | May 28, 2025 |
| K241733 | novasonix technology s.l | HEBE (NP0000763) | April 16, 2025 |
| K243055 | ema aesthetics | Préime DermaFacial Collagen+ | April 15, 2025 |
| K242175 | xod | XOD Diathermia Radiofrequency Device | February 27, 2025 |
| K241107 | indiba s. a. u | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); I | January 24, 2025 |
| K232966 | golden star | FISIOWARM 7.0 | December 26, 2024 |
| K242553 | general vibronics | MIRARI® Cold Plasma System ( GV-M2-01) | November 21, 2024 |
| K243164 | indiba s. a. u | INDIBA COMPACT devices | November 20, 2024 |
| K242598 | inmode | DEFINE System (AG612444A) | November 14, 2024 |
| K240991 | weero co | eMVFit (MVF-10M) | October 9, 2024 |
| K240178 | zimmer medizinsysteme | RFG-01 | July 15, 2024 |
| K230755 | bios | NuEra Tight RF Model OptiStream | October 30, 2023 |
| K230037 | swims america | BACK 3 | July 19, 2023 |
| K230659 | termosalud | Zionic Aesthetic | June 8, 2023 |
| K213256 | zimmer medizinsysteme | ThermoTK | May 25, 2023 |
| K223907 | bios | NuEra Tight RF Model APMD145.M70-US | May 2, 2023 |