Product code PBX
- Device name
- Massager, Vacuum, Radio Frequency Induced Heat
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4400
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260647 | SPECCHIO | El.En S.P.A. | 2026-04-02 |
| K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-03-13 |
| K252888 | NeoSculpt Plus | S&M Medical Co., Ltd. | 2026-03-09 |
| K250734 | OptiLUV Device | Pollogen, Ltd. | 2025-09-10 |
| K250916 | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. | 2025-08-14 |
| K243716 | Zionic Pro Max (Radiofrequency) | Termosalud S.L. | 2025-05-28 |
| K241733 | HEBE (NP0000763) | Novasonix Technology S.L. | 2025-04-16 |
| K243055 | Préime DermaFacial Collagen+ | EMA Aesthetics , Ltd. | 2025-04-15 |
| K242175 | XOD Diathermia Radiofrequency Device | Xod, Inc. | 2025-02-27 |
| K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) | Indiba S. A. U. | 2025-01-24 |
| K232966 | FISIOWARM 7.0 | Golden Star Srl | 2024-12-26 |
| K242553 | MIRARI® Cold Plasma System ( GV-M2-01) | General Vibronics, Inc. | 2024-11-21 |
| K243164 | INDIBA COMPACT devices | Indiba S. A. U. | 2024-11-20 |
| K242598 | DEFINE System (AG612444A) | InMode , Ltd. | 2024-11-14 |
| K240991 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-09 |
| K240178 | RFG-01 | Zimmer Medizinsysteme GmbH | 2024-07-15 |
| K230755 | NuEra Tight RF Model OptiStream | Bios S.R.L. | 2023-10-30 |
| K230037 | BACK 3 | Swims America Corp | 2023-07-19 |
| K230659 | Zionic Aesthetic | Termosalud | 2023-06-08 |
| K213256 | ThermoTK | Zimmer Medizinsysteme GmbH | 2023-05-25 |
| K223907 | NuEra Tight RF Model APMD145.M70-US | Bios S.R.L. | 2023-05-02 |
| K230412 | Symmed Elite Aesthetic | Termosalud | 2023-04-13 |
| K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | Capenergy Medical S.L. | 2023-03-28 |
| K220014 | RSHOCK | Swims America Corp | 2023-03-01 |
| K221043 | Doctor Tecar Plus, Doctor Tecar Smart | Mectronic Medicale S.R.L. | 2023-02-17 |
| K213295 | C.C. LIFE 21 | 21 Equipment S.R.L. | 2022-11-17 |
| K214090 | Back 3 COLOR | Swims America Corp | 2022-11-01 |
| K214015 | Palm NRG cellulite body device (model: Palm NRG body device) | Heat IN A Click, LLC | 2022-09-26 |
| K212253 | Apollo Duet (Model : APD-4000) | Weero Co. | 2022-08-25 |
| K211207 | Diacare 7000 | Globus Sport and Health Technologies, LLC | 2022-06-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810060832851 | Venus Nova | Venus Concept Inc. | 2026-04-15 |
| 08800016905052 | QUADESSY Main Unit | CLASSYS Inc. | 2025-07-02 |
| 08800016905045 | QUADESSY Set Package | CLASSYS Inc. | 2025-07-02 |
| 08053782383283 | T-SHAPE 2 | B&M SRL MARKETING NEL BENESSERE | 2025-04-11 |
| 08434251004791 | COMPACT LITE | INDIBA SA. | 2025-01-29 |
| 08434251004814 | COMPACT PLUS | INDIBA SA. | 2025-01-29 |
| 08434251004838 | COMPACT PRO | INDIBA SA. | 2025-01-29 |
| B108785PO9MUS00 | BTL-785F | BTL INDUSTRIES LIMITED | 2023-12-01 |
| B108785PO8MUS00 | BTL-785F | BTL INDUSTRIES LIMITED | 2023-12-01 |
| B108785PO2MUS00 | BTL-785F | BTL INDUSTRIES LIMITED | 2023-10-20 |
| B108785PO6MUS10 | BTL-785L | BTL INDUSTRIES LIMITED | 2023-06-28 |
| 00810060830987 | Venus Bliss Max | Venus Concept Inc. | 2023-06-08 |
| B108785PO7MUS00 | BTL-785F | BTL INDUSTRIES LIMITED | 2023-05-02 |
| B108785PO6MUS00 | BTL-785L | BTL INDUSTRIES LIMITED | 2023-05-02 |
| B108785PO5MUS00 | BTL-785F | BTL INDUSTRIES LIMITED | 2022-07-18 |
| B108784POEMTENUS0100 | EMTONE | BTL INDUSTRIES LIMITED | 2019-08-16 |
| B108284AP01EMTENUS0100 | EMTONE applicator | BTL INDUSTRIES LIMITED | 2019-08-16 |
| 08434251000014 | INDIBA ACTIV - ACTIV 902 | INDIBA SA. | 2019-02-22 |
| 08434251000311 | INDIBA DEEP CARE - RGN | INDIBA SA. | 2019-02-22 |
| 08434251000267 | INDIBA DEEP CARE - PREMIUM NS | INDIBA SA. | 2019-02-22 |
| 08434251000250 | INDIBA DEEP CARE - ELITE NS | INDIBA SA. | 2019-02-22 |
| 08434251000243 | INDIBA ACTIV - CT7 | INDIBA SA. | 2019-02-22 |
| 08434251000236 | INDIBA ACTIV - CT8 | INDIBA SA. | 2019-02-22 |
| 08434251000052 | INDIBA DEEP CARE - PREMIUM | INDIBA SA. | 2019-02-22 |
| 08434251000045 | INDIBA DEEP CARE - ELITE | INDIBA SA. | 2019-02-22 |
| 08434251000038 | INDIBA ACTIV - ACTIV 701 | INDIBA SA. | 2019-02-22 |
| 08434251000021 | INDIBA ACTIV - ACTIV 801 | INDIBA SA. | 2019-02-22 |
| 00816722021427 | truSculpt iD | CUTERA, INC. | 2018-06-27 |
| 10841494107908 | ASSY, Probe Kit, 5 PK, TempSure Vitalia | Cynosure, LLC | 2018-04-02 |
| 00816722021410 | truSculpt | CUTERA, INC. | 2017-03-21 |