FDA 510(k) Applications for Medical Device Product Code "PBX"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K213295 | 21 Equipment S.R.L. | C.C. LIFE 21 | 11/17/2022 |
| K151296 | BIOS S.R.L. | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | 11/19/2015 |
| K223907 | BIOS s.r.l. | NuEra Tight RF Model APMD145.M70-US | 05/02/2023 |
| K230755 | BIOS s.r.l. | NuEra Tight RF Model OptiStream | 10/30/2023 |
| K210867 | BIOS s.r.l. | NuEra Tight RF, NuEra Tight RF Plus | 04/21/2021 |
| K200359 | Bios s.r.l. | NuEra Tight, NuEra Tight EMS | 08/11/2020 |
| K143040 | BTL INDUSTRIES INC | Exilis XP | 01/15/2015 |
| K190023 | BTL Industries, Inc. | BTL-084 | 03/29/2019 |
| K163176 | BTL Industries, Inc. | Exilis XP II | 01/12/2017 |
| K161551 | BTL INDUSTRIES, INC. | TR-100 | 09/13/2016 |
| K150720 | BTL Industries, Inc. | XP3000 | 09/16/2015 |
| K171052 | CAO Group, Inc. | Ultimate Contour, Ultimate Contour Mini | 10/20/2017 |
| K201475 | CAO Group, Inc. | Ultimate Contour, Ultimate Contour Mini | 10/28/2020 |
| K222260 | Capenergy Medical S.L. | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | 03/28/2023 |
| K191202 | Capenergy Medical SL | CAPENERGY - C100, C200, C300, C400, C50 | 02/11/2020 |
| K122389 | CUTERA, INC. | TRUSCULPT | 11/02/2012 |
| K133739 | CUTERA, INC. | TRUSCULPT | 09/05/2014 |
| K162512 | CUTERA, INC. | truSculpt | 12/09/2016 |
| K172004 | Cutera, Inc. | truSculpt | 08/02/2017 |
| K180709 | Cutera, Inc. | truSculpt RF Device; truSculpt; truSculpt 3D | 06/06/2018 |
| K200241 | Cynosure LLC | TempSure System | 03/25/2020 |
| K181095 | EL Global Trade Ltd | RF-Relief | 07/24/2018 |
| K170637 | EL Global Trade Ltd | sensiFirm | 07/14/2017 |
| K183371 | El..En. Electroic Engineering SpA | Deka Tiac 1 | 12/03/2019 |
| K211091 | EL.EN Electronic Engineering Spa | Deka Tiac II | 10/15/2021 |
| K132949 | ELLMAN INTERNATIONAL, INC. | PELLEFIRM | 02/20/2014 |
| K243055 | EMA Aesthetics, LTD | PrΘime DermaFacial Collagen+ | 04/15/2025 |
| K161199 | ENDYMED MEDICAL LTD. | EndyMed Contour Handpiece | 08/01/2016 |
| K242553 | General Vibronics, Inc. | MIRARI« Cold Plasma System ( GV-M2-01) | 11/21/2024 |
| K211207 | Globus Sport and Health Technologies LLC | Diacare 7000 | 06/06/2022 |
| K232966 | Golden Star Srl | FISIOWARM 7.0 | 12/26/2024 |
| K191940 | Heat In A Click | Palm NRG cellulite and muscle toning body device | 11/03/2020 |
| K214015 | Heat In A Click LLC. | Palm NRG cellulite body device (model: Palm NRG body device) | 09/26/2022 |
| K243164 | INDIBA S. A. U. | INDIBA COMPACT devices | 11/20/2024 |
| K241107 | INDIBA S.A.U | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) | 01/24/2025 |
| K161458 | Indiba USA Inc. | Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care | 10/03/2016 |
| K242598 | InMode Ltd. | DEFINE System (AG612444A) | 11/14/2024 |
| K210877 | InMode Ltd. | Evolve System with the T3 Applicator | 07/19/2021 |
| K183450 | InMode MD Ltd. | EmBody System | 06/20/2019 |
| K191855 | InMode MD Ltd. | EmFace Device | 10/29/2019 |
| K172302 | InMode MD Ltd. | InMode PLUS System | 12/08/2017 |
| K153568 | InMode MD Ltd. | InMode Plus System | 07/12/2016 |
| K160329 | InMode MD Ltd. | InMode System MiniFX Handpiece | 08/19/2016 |
| K210129 | Luvo Medical Technologies, Inc | RF Thermal System | 07/20/2021 |
| K183693 | Mectronic Medicale S.r.l. | Doctor Tecar | 02/22/2019 |
| K221043 | Mectronic Medicale S.r.l. | Doctor Tecar Plus, Doctor Tecar Smart | 02/17/2023 |
| K202780 | Neauvia North America | Sectum | 07/30/2021 |
| K241733 | Novasonix Technology S.L | HEBE (NP0000763) | 04/16/2025 |
| K230037 | SWIMS America Corp | BACK 3 | 07/19/2023 |
| K214090 | SWIMS America Corp | Back 3 COLOR | 11/01/2022 |
| K220014 | SWIMS America Corp | RSHOCK | 03/01/2023 |
| K161043 | SYNERON CANDELA CORPORATION | Profound System | 09/12/2016 |
| K230412 | TermoSalud | Symmed Elite Aesthetic | 04/13/2023 |
| K230659 | TermoSalud | Zionic Aesthetic | 06/08/2023 |
| K243716 | TermoSalud S.L. | Zionic Pro Max (Radiofrequency) | 05/28/2025 |
| K181211 | UNIBELL S.r.l | Human Tecar HCR 1002 | 09/10/2018 |
| K143554 | Venus Concept Ltd. | Venus Legacy CX | 08/04/2015 |
| K182094 | Venus Concept USA Inc. | Family of Venus RF Systems - Heal | 02/01/2019 |
| K211461 | Venus Concept USA Inc. | Family of Venus RF Systems - Venus Freedom | 10/14/2021 |
| K190743 | Venus Concept USA Inc. | Venus Bliss | 06/25/2019 |
| K213308 | Venus Concept USA Inc. | Venus BlissMAX | 01/12/2022 |
| K220592 | Venus Concept USA Inc. | Venus BlissMAX | 04/27/2022 |
| K150035 | VIORA LTD. | V10 system | 05/01/2015 |
| K200468 | Viora Ltd. | V30 system, V20 system, V10 system, V-FC Handpiece | 05/21/2020 |
| K201064 | Viora Ltd. | V30 System, V20 System, V10 System, V-FR Handpiece | 07/15/2020 |
| K202247 | Viora Ltd. | V30 system, V20 system, V10 system, V-VR Hand piece | 12/09/2020 |
| K212253 | Weero Co. | Apollo Duet (Model : APD-4000) | 08/25/2022 |
| K240991 | Weero Co., Ltd. | eMVFit (MVF-10M) | 10/09/2024 |
| K162828 | WINBACK USA CORP | Winback Back 3SE | 09/18/2017 |
| K181893 | Wintecare SA | T-PLUS | 01/29/2019 |
| K242175 | XOD Inc. | XOD Diathermia Radiofrequency Device | 02/27/2025 |
| K240178 | Zimmer MedizinSysteme GmbH | RFG-01 | 07/15/2024 |
| K213256 | Zimmer MedizinSysteme GmbH | ThermoTK | 05/25/2023 |
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