PBX — Massager, Vacuum, Radio Frequency Induced Heat Class II
FDA product code PBX covers "Massager, Vacuum, Radio Frequency Induced Heat", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253480 | capenergy medical s.l | Capenergy C Equipments RF C200 and C400 Drakarian | July 10, 2026 |
| K260647 | el.en | SPECCHIO | April 2, 2026 |
| 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 |