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Panels › General, Plastic Surgery › Product code PBX · Class 2

Massager, Vacuum, Radio Frequency Induced Heat

Regulation 878.4400

6510(k)s in 12 months (81 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in PBX

Company510(k)sRecalls
Bios S.R.L.51
Venus Concept , Ltd.60
BTL Industries, Inc.50
Cutera, Inc.50
Inmode MD , Ltd.50
Viora , Ltd.40
Capenergy Medical S.L.30
Swims America Corp30
Weero Co.30
CAO Group, Inc.20
Decided510(k)Device and applicantCode
Oct 13, 2026K252288TECAR Therapy Device (TC2000, TC2001)
Shenzhen Dongdixin Technology Co., Ltd., CN
PBX
Sep 22, 2026K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)
Bh Group Us, LLC
PBX
Jul 10, 2026K253480Capenergy C Equipments RF C200 and C400 Drakarian
Capenergy Medical S.L., ES
PBX
Apr 2, 2026K260647SPECCHIO
El.En S.P.A., IT
PBX
Mar 13, 2026K253261Apollo Quattro (APQ-10M)
Weero Co., Ltd., KR
PBX
Mar 9, 2026K252888NeoSculpt Plus
S&M Medical Co., Ltd., KR
PBX
Sep 10, 2025K250734OptiLUV Device
Pollogen, Ltd., IL
PBX
Aug 14, 2025K250916WinForth (LM-E470KA)
Shenzhen Leaflife Technology Co., Ltd., CN
PBX
May 28, 2025K243716Zionic Pro Max (Radiofrequency)
Termosalud S.L., ES
PBX
Apr 16, 2025K241733HEBE (NP0000763)
Novasonix Technology S.L., ES
PBX
Apr 15, 2025K243055Préime DermaFacial Collagen+
EMA Aesthetics , Ltd., IE
PBX
Feb 27, 2025K242175XOD Diathermia Radiofrequency Device
Xod, Inc.
PBX
Jan 24, 2025K241107Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ De
Indiba S. A. U., ES
PBX
Dec 26, 2024K232966FISIOWARM 7.0
Golden Star Srl, IT
PBX
Nov 21, 2024K242553MIRARI® Cold Plasma System ( GV-M2-01)
General Vibronics, Inc.
PBX
Nov 20, 2024K243164INDIBA COMPACT devices
Indiba S. A. U., ES
PBX
Nov 14, 2024K242598DEFINE System (AG612444A)
InMode , Ltd., IL
PBX
Oct 9, 2024K240991eMVFit (MVF-10M)
Weero Co., Ltd., KR
PBX
Jul 15, 2024K240178RFG-01
Zimmer Medizinsysteme GmbH, DE
PBX
Oct 30, 2023K230755NuEra Tight RF Model OptiStream
Bios S.R.L., IT
PBX
Jul 19, 2023K230037BACK 3
Swims America Corp
PBX
Jun 8, 2023K230659Zionic Aesthetic
Termosalud, ES
PBX
May 25, 2023K213256ThermoTK
Zimmer Medizinsysteme GmbH, DE
PBX
May 2, 2023K223907NuEra Tight RF Model APMD145.M70-US
Bios S.R.L., IT
PBX
Apr 13, 2023K230412Symmed Elite Aesthetic
Termosalud, ES
PBX
Mar 28, 2023K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
Capenergy Medical S.L., ES
PBX
Mar 1, 2023K220014RSHOCK
Swims America Corp
PBX
Feb 17, 2023K221043Doctor Tecar Plus, Doctor Tecar Smart
Mectronic Medicale S.R.L., IT
PBX
Nov 17, 2022K213295C.C. LIFE 21
21 Equipment S.R.L., IT
PBX
Nov 1, 2022K214090Back 3 COLOR
Swims America Corp
PBX
Sep 26, 2022K214015Palm NRG cellulite body device (model: Palm NRG body device)
Heat IN A Click, LLC
PBX
Aug 25, 2022K212253Apollo Duet (Model : APD-4000)
Weero Co., KR
PBX
Jun 6, 2022K211207Diacare 7000
Globus Sport and Health Technologies, LLC
PBX
Apr 27, 2022K220592Venus BlissMAX
Venus Concept USA, Inc.
PBX
Jan 12, 2022K213308Venus BlissMAX
Venus Concept USA, Inc.
PBX
Oct 15, 2021K211091Deka Tiac II
El.En Electronic Engineering Spa, IT
PBX
Oct 14, 2021K211461Family of Venus RF Systems - Venus Freedom
Venus Concept USA, Inc.
PBX
Jul 30, 2021K202780Sectum
Neauvia North America
PBX
Jul 20, 2021K210129RF Thermal System
Luvo Medical Technologies, Inc., CA
PBX
Jul 19, 2021K210877Evolve System with the T3 Applicator
InMode , Ltd., IL
PBX
Apr 21, 2021K210867NuEra Tight RF, NuEra Tight RF Plus
Bios S.R.L., IT
PBX
Dec 9, 2020K202247V30 system, V20 system, V10 system, V-VR Hand piece
Viora , Ltd., IL
PBX
Nov 3, 2020K191940Palm NRG cellulite and muscle toning body device
Heat IN A Click
PBX
Oct 28, 2020K201475Ultimate Contour, Ultimate Contour Mini
CAO Group, Inc.
PBX
Aug 11, 2020K200359NuEra Tight, NuEra Tight EMS
Bios S.R.L., IT
PBX
Jul 15, 2020K201064V30 System, V20 System, V10 System, V-FR Handpiece
Viora , Ltd., IL
PBX
May 21, 2020K200468V30 system, V20 system, V10 system, V-FC Handpiece
Viora , Ltd., IL
PBX
Mar 25, 2020K200241TempSure System
Cynosure, LLC
PBX
Feb 11, 2020K191202CAPENERGY - C100, C200, C300, C400, C50
Capenergy Medical S.L., ES
PBX
Dec 3, 2019K183371Deka Tiac 1
El..En. Electroic Engineering Spa, IT
PBX

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