FDA.reportPublic FDA data

Percutaneous radio-frequency ablation system generator

Definition
An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).
GUDID devices
83
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00818788021892Epimed International, Inc.EPIMED INTERNATIONAL, INC325-4LRFG2025-11-21
00850055552128Bella Turbo 10 HandpieceInbella Medical IncNP102206D2026-03-31
00850055552173Bella Turbo 25 HandpieceInbella Medical IncNP253966D2026-03-31
00850055552616Bella Body HandpieceInbella Medical IncNP172296D2026-03-31
00850055552623Bella Face HandpieceInbella Medical IncNP101396D2026-03-31
00850055552692Bella AccuTite HandpieceInbella Medical IncNP060999D2026-03-31
04712978252058AblatePal Radiofrequency Ablation SystemCompal Electronics, Inc.HFM01-MD22022026-05-13
05425025630080EVRFF Care Systems00EVRFV22026-04-08
05425025630288Viridex RFF Care Systems00ViridexRF2026-04-08
05425025630530MedRF4000F Care Systems00MEDRF40002026-03-30
05425025630554ThermaVein+F Care Systems00thermaVeinplus2026-04-08
05425025634507MedRF4000F Care Systems00MEDRF4000US2026-03-30
06955139299990NAAcotec Scientific Co., Ltd.ERA-G5-US2025-11-21
08809306769251TS-RF GeneratorSTARMED CO.,LTDSTS102025-12-01
00191506048464GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFG-X1-120V2025-09-29
00191506048518GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFG-X1-220V2025-09-29
00191506048563GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONRFG-X1-240V2025-09-29
00191506059309GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONGX1-SYS-ROW2025-09-29
00191506059330GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATION51779845-012025-09-29
00191506059347GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATION51779845-022025-09-29
00191506059354GX1™BOSTON SCIENTIFIC NEUROMODULATION CORPORATION51779845-032025-09-29
08809295147023Mygen™ RF Generator M-3004RF Medical Co.,Ltd.M-30042025-09-05
00856895008153One RF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONNRFPK0001-TNRF2025-09-01
06936666559269CurawayZhejiang CuraWay Medical Technology Co., Ltd.JM-S402025-08-11
06936666590651CurawayZhejiang CuraWay Medical Technology Co., Ltd.CR-S20002025-08-11
07290019863359ApexRF ApplicatorINMODE M.D LTDAG614409A2025-06-04
00817771029365ThermiRFCelling BiosciencesThermiRF VA2025-04-11
00817771029396ThermiRF+Celling BiosciencesThermiRF+-R2025-04-11
00817771029501ThermiRFCelling BiosciencesThermiRF Eye2025-04-11
00817771029655ThermiRFCelling BiosciencesThermiRF Smooth2025-04-11
00817771029723ThermiRFCelling BiosciencesThermiRF-R2025-04-11
07290019863342APEX RF SystemINMODE M.D LTDAG614329A2025-01-09
00850062978010NuSkin RF MicroWORLD AESTHETIX LLCWAX2317492024-12-13
00763000764012OsteoCool™ 2.0 RF Ablation SystemMEDTRONIC SOFAMOR DANEK, INC.OC01-R-1002024-11-15
00763000764036OsteoCool™ 2.0 RF Ablation SystemMEDTRONIC SOFAMOR DANEK, INC.OC02-R-1002024-11-15
00763000764067OsteoCool™ 2.0 RF Ablation SystemMEDTRONIC SOFAMOR DANEK, INC.OC03-1002024-11-15
08809306769244VVR GeneratorSTARMED CO.,LTDVVR102024-09-30
00860011603665SPINERY GeneratorAXON SRLSPINERY2024-05-27
00763000764005OsteoCool™ 2.0 RF Ablation SystemMEDTRONIC SOFAMOR DANEK, INC.OC01-1002024-03-23
00763000764029OsteoCool™ 2.0 RF Ablation SystemMEDTRONIC SOFAMOR DANEK, INC.OC02-1002024-03-23
00763000764043OsteoCool™ 2.0 RF Ablation SystemMEDTRONIC SOFAMOR DANEK, INC.OC04-1002024-03-23
00856895008498OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONNRFGN00012024-03-15
00856895008504OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONNRFGS00012024-03-15
00856895008511OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONNRFBK00012024-03-15
00856895008528OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONNRFGC00012024-03-15
00856895008535OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONNRFFP00012024-03-15
00856895008559OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONNRFCH00012024-03-15
00856895008566OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONNRFPK00012024-03-15
00852454006288RelievantRelievant Medsystems, Inc.FG 00522022-12-09
00763000387020Symplicity G3™MEDTRONIC, INC.RDNG3A2023-11-30
06976264730073Radio Frequency SystemSHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTDRF-3012023-11-17
06976264730080Microneedle electrodesSHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD25-Pin2023-11-17
06976264730097Microneedle electrodesSHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD49-Pin2023-11-17
06976264730103RF electrodesSHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD49-RF2023-11-17
00817771029044ThermiRF+Celling BiosciencesThermiRF+2023-09-17
00817771029051ThermiRFCelling BiosciencesThermiRF2023-09-17
00817771029068ArvatiCelling BiosciencesArvati2023-09-17
00817771029181(Certified) ThermiRF+Celling Biosciences(Certified) ThermiRF+2023-09-17
30680651124914Pain Management GeneratorAvanos Medical, Inc.PMG-2302023-06-23
00825114000032OWLDiros Technology IncURF-2AP2023-06-19
08055510890087ATTIVAITALIAN ENGINEERING SRLMD012023-03-20
07290016633320InMode RF Multi-SystemINMODE M.D LTDAG606968A2022-10-26
07290016633405InMode RF hand pieceINMODE M.D LTDHP172246A2022-10-25
07613327547610OPTABLATESTRYKER CORPORATION97000000002022-09-23
00817371020618ThermiRF+ThermiThermiRF+2022-09-05
08714729779896Maestro 3000™ PodBOSTON SCIENTIFIC CORPORATIONM00421870TR02016-09-24
08714729790006Maestro 3000™ Remote Control PanelBOSTON SCIENTIFIC CORPORATIONM00421880R02015-10-14
08714729811923Maestro 3000™BOSTON SCIENTIFIC CORPORATIONM00421000TCR02014-11-11
08714729821755Maestro 3000® RF Cardiac Ablation Pod 100BOSTON SCIENTIFIC CORPORATIONM00421860TR02015-10-14
08714729861911Maestro 4000™ ControllerBOSTON SCIENTIFIC CORPORATIONM004400002015-01-27
08714729861928Maestro 4000™ ControllerBOSTON SCIENTIFIC CORPORATIONM0044000D02017-11-06
08714729861935Maestro 4000™ ControllerBOSTON SCIENTIFIC CORPORATIONM0044000H02018-03-19
08714729861942Maestro 4000™ ControllerBOSTON SCIENTIFIC CORPORATIONM0044000R02015-01-27
08714729861966Maestro 4000™ Pod, 100WBOSTON SCIENTIFIC CORPORATIONM004401002015-01-27
08714729861980Maestro 4000™ Pod, 100WBOSTON SCIENTIFIC CORPORATIONM0044010R02015-01-27
08714729861997Maestro 4000™ Pod, 100WBOSTON SCIENTIFIC CORPORATIONM0044010D02017-11-06
08714729862062Maestro 4000™ Remote ControlBOSTON SCIENTIFIC CORPORATIONM004402002015-01-27
08714729862093Maestro 4000™ Remote ControlBOSTON SCIENTIFIC CORPORATIONM0044020R02015-01-27
08809295147030RF ABLATION SYSTEM V-1000RF Medical Co.,Ltd.V-10002019-07-31
10680651422979COOLIEF* Cooled Radiofrequency Pain Management GeneratorAvanos Medical, Inc.422972016-09-30