FDA Product Code
FDA Product Code PBX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 80 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243223 | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | Bh Group Us, LLC | 2026-09-22 | Traditional | PDF ↗ |
| K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 2026-07-10 | Abbreviated | PDF ↗ |
| K260647 | SPECCHIO | El.En S.P.A. | 2026-04-02 | Special | PDF ↗ |
| K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-03-13 | Traditional | PDF ↗ |
| K252888 | NeoSculpt Plus | S&M Medical Co., Ltd. | 2026-03-09 | Traditional | PDF ↗ |
| K250734 | OptiLUV Device | Pollogen, Ltd. | 2025-09-10 | Traditional | PDF ↗ |
| K250916 | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. | 2025-08-14 | Traditional | PDF ↗ |
| K243716 | Zionic Pro Max (Radiofrequency) | Termosalud S.L. | 2025-05-28 | Traditional | PDF ↗ |
| K241733 | HEBE (NP0000763) | Novasonix Technology S.L. | 2025-04-16 | Traditional | PDF ↗ |
| K243055 | Préime DermaFacial Collagen+ | EMA Aesthetics , Ltd. | 2025-04-15 | Traditional | PDF ↗ |
| K242175 | XOD Diathermia Radiofrequency Device | Xod, Inc. | 2025-02-27 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K232966 | FISIOWARM 7.0 | Golden Star Srl | 2024-12-26 | Traditional | PDF ↗ |
| K242553 | MIRARI® Cold Plasma System ( GV-M2-01) | General Vibronics, Inc. | 2024-11-21 | Traditional | PDF ↗ |
| K243164 | INDIBA COMPACT devices | Indiba S. A. U. | 2024-11-20 | Traditional | PDF ↗ |
| K242598 | DEFINE System (AG612444A) | InMode , Ltd. | 2024-11-14 | Special | PDF ↗ |
| K240991 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-09 | Traditional | PDF ↗ |
| K240178 | RFG-01 | Zimmer Medizinsysteme GmbH | 2024-07-15 | Traditional | PDF ↗ |
| K230755 | NuEra Tight RF Model OptiStream | Bios S.R.L. | 2023-10-30 | Traditional | PDF ↗ |
| K230037 | BACK 3 | Swims America Corp | 2023-07-19 | Traditional | PDF ↗ |
| K230659 | Zionic Aesthetic | Termosalud | 2023-06-08 | Traditional | PDF ↗ |
| K213256 | ThermoTK | Zimmer Medizinsysteme GmbH | 2023-05-25 | Traditional | PDF ↗ |
| K223907 | NuEra Tight RF Model APMD145.M70-US | Bios S.R.L. | 2023-05-02 | Special | PDF ↗ |
| K230412 | Symmed Elite Aesthetic | Termosalud | 2023-04-13 | Traditional | PDF ↗ |
| K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | Capenergy Medical S.L. | 2023-03-28 | Abbreviated | PDF ↗ |
| K220014 | RSHOCK | Swims America Corp | 2023-03-01 | Traditional | PDF ↗ |
| K221043 | Doctor Tecar Plus, Doctor Tecar Smart | Mectronic Medicale S.R.L. | 2023-02-17 | Traditional | PDF ↗ |
| K213295 | C.C. LIFE 21 | 21 Equipment S.R.L. | 2022-11-17 | Traditional | PDF ↗ |
| K214090 | Back 3 COLOR | Swims America Corp | 2022-11-01 | Traditional | PDF ↗ |
| K214015 | Palm NRG cellulite body device (model: Palm NRG body device) | Heat IN A Click, LLC | 2022-09-26 | Traditional | PDF ↗ |
| K212253 | Apollo Duet (Model : APD-4000) | Weero Co. | 2022-08-25 | Traditional | PDF ↗ |
| K211207 | Diacare 7000 | Globus Sport and Health Technologies, LLC | 2022-06-06 | Traditional | PDF ↗ |
| K220592 | Venus BlissMAX | Venus Concept USA, Inc. | 2022-04-27 | Traditional | PDF ↗ |
| K213308 | Venus BlissMAX | Venus Concept USA, Inc. | 2022-01-12 | Traditional | PDF ↗ |
| K211091 | Deka Tiac II | El.En Electronic Engineering Spa | 2021-10-15 | Traditional | PDF ↗ |
| K211461 | Family of Venus RF Systems - Venus Freedom | Venus Concept USA, Inc. | 2021-10-14 | Traditional | PDF ↗ |
| K202780 | Sectum | Neauvia North America | 2021-07-30 | Traditional | PDF ↗ |
| K210129 | RF Thermal System | Luvo Medical Technologies, Inc. | 2021-07-20 | Traditional | PDF ↗ |
| K210877 | Evolve System with the T3 Applicator | InMode , Ltd. | 2021-07-19 | Traditional | PDF ↗ |
| K210867 | NuEra Tight RF, NuEra Tight RF Plus | Bios S.R.L. | 2021-04-21 | Special | PDF ↗ |
| K202247 | V30 system, V20 system, V10 system, V-VR Hand piece | Viora , Ltd. | 2020-12-09 | Traditional | PDF ↗ |
| K191940 | Palm NRG cellulite and muscle toning body device | Heat IN A Click | 2020-11-03 | Traditional | PDF ↗ |
| K201475 | Ultimate Contour, Ultimate Contour Mini | CAO Group, Inc. | 2020-10-28 | Traditional | PDF ↗ |
| K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | 2020-08-11 | Traditional | PDF ↗ |
| K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | Viora , Ltd. | 2020-07-15 | Traditional | PDF ↗ |
| K200468 | V30 system, V20 system, V10 system, V-FC Handpiece | Viora , Ltd. | 2020-05-21 | Traditional | PDF ↗ |
| K200241 | TempSure System | Cynosure, LLC | 2020-03-25 | Traditional | PDF ↗ |
| K191202 | CAPENERGY - C100, C200, C300, C400, C50 | Capenergy Medical S.L. | 2020-02-11 | Traditional | PDF ↗ |
| K183371 | Deka Tiac 1 | El..En. Electroic Engineering Spa | 2019-12-03 | Traditional | PDF ↗ |
| K191855 | EmFace Device | Inmode MD , Ltd. | 2019-10-29 | Traditional | PDF ↗ |
| K190743 | Venus Bliss | Venus Concept USA, Inc. | 2019-06-25 | Traditional | PDF ↗ |
| K183450 | EmBody System | Inmode MD , Ltd. | 2019-06-20 | Traditional | PDF ↗ |
| K190023 | BTL-084 | BTL Industries, Inc. | 2019-03-29 | Traditional | PDF ↗ |
| K183693 | Doctor Tecar | Mectronic Medicale S.R.L. | 2019-02-22 | Traditional | PDF ↗ |
| K182094 | Family of Venus RF Systems - Heal | Venus Concept USA, Inc. | 2019-02-01 | Special | PDF ↗ |
| K181893 | T-PLUS | Wintecare SA | 2019-01-29 | Traditional | PDF ↗ |
| K181211 | Human Tecar HCR 1002 | Unibell S.R.L | 2018-09-10 | Traditional | PDF ↗ |
| K181095 | RF-Relief | El Global Trade, Ltd. | 2018-07-24 | Traditional | PDF ↗ |
| K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | Cutera, Inc. | 2018-06-06 | Traditional | PDF ↗ |
| K172302 | InMode PLUS System | Inmode MD , Ltd. | 2017-12-08 | Traditional | PDF ↗ |
| K171052 | Ultimate Contour, Ultimate Contour Mini | CAO Group, Inc. | 2017-10-20 | Traditional | PDF ↗ |
| K162828 | Winback Back 3SE | Winback USA Corp | 2017-09-18 | Traditional | PDF ↗ |
| K172004 | truSculpt | Cutera, Inc. | 2017-08-02 | Special | PDF ↗ |
| K170637 | sensiFirm | El Global Trade, Ltd. | 2017-07-14 | Traditional | PDF ↗ |
| K163176 | Exilis XP II | BTL Industries, Inc. | 2017-01-12 | Traditional | PDF ↗ |
| K162512 | truSculpt | Cutera, Inc. | 2016-12-09 | Traditional | PDF ↗ |
| K161458 | Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care | Indiba USA, Inc. | 2016-10-03 | Traditional | PDF ↗ |
| K161551 | TR-100 | BTL Industries, Inc. | 2016-09-13 | Traditional | PDF ↗ |
| K161043 | Profound System | Syneron Candela Corporation | 2016-09-12 | Traditional | PDF ↗ |
| K160329 | InMode System MiniFX Handpiece | Inmode MD , Ltd. | 2016-08-19 | Traditional | PDF ↗ |
| K161199 | EndyMed Contour Handpiece | Endymed Medical, Ltd. | 2016-08-01 | Traditional | PDF ↗ |
| K153568 | InMode Plus System | Inmode MD , Ltd. | 2016-07-12 | Traditional | PDF ↗ |
| K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Bios S.R.L. | 2015-11-19 | Traditional | PDF ↗ |
| K150720 | XP3000 | BTL Industries, Inc. | 2015-09-16 | Traditional | PDF ↗ |
| K143554 | Venus Legacy CX | Venus Concept , Ltd. | 2015-08-04 | Traditional | PDF ↗ |
| K150035 | V10 system | Viora , Ltd. | 2015-05-01 | Traditional | PDF ↗ |
| K143040 | Exilis XP | BTL Industries, Inc. | 2015-01-15 | Traditional | PDF ↗ |
| K133739 | TRUSCULPT | Cutera, Inc. | 2014-09-05 | Traditional | PDF ↗ |
| K132949 | PELLEFIRM | Ellman International, Inc. | 2014-02-20 | Traditional | PDF ↗ |
| K122389 | TRUSCULPT | Cutera, Inc. | 2012-11-02 | Special | PDF ↗ |
Product code PBX · Class II · General, Plastic Surgery. Data: openFDA.