FDA.reportPublic FDA data

Electrosurgical system

Definition
An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.
GUDID devices
611
Last updated
2023-03-22 07:48:18

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860008655806PlasmageBRERA MEDICAL INC12023-03-14
05391537940095NEUROMARK® DeviceNEURENT MEDICAL LIMITEDFS-004-012023-02-01
05391537940118NEUROMARK® Radiofrequency ConsoleNEURENT MEDICAL LIMITED010-00089-0002023-02-01
00810026181931RF GeneratorSONIQUENCE, LLCIEC6-IESP1202022-11-06
08800023201444ACUTRONILOODA.CO.,LTDAcuTron2022-10-27
08800023201895ToRRILOODA.CO.,LTDMTX-C12022-10-27
00190776213794MillenniumAvalign Technologies, Inc.72-53562022-10-25
08886479300238RhinAer® StylusAerin Medical Inc.FG13932022-08-19
08809502330149XE25VIOL Co.,Ltd.J25BM2022-06-29
08809502330156XA25VIOL Co.,Ltd.J25BS2022-06-29
08809502330163XW18VIOL Co.,Ltd.J18BS2022-06-29
05391537940002NEUROMARK™ DeviceNEURENT MEDICAL LIMITEDFS-0022022-04-26
05391537940026NEUROMARK™ Radiofrequency GeneratorNEURENT MEDICAL LIMITED010-00043-0002022-04-26
18800020101133POTENZA TipJeisys Medical Inc.A1-122022-03-29
18800020101140POTENZA TipJeisys Medical Inc.A1-152022-03-29
18800020101157POTENZA TipJeisys Medical Inc.C21-1 Tip2022-03-29
18800020101164POTENZA TipJeisys Medical Inc.C21-2 Tip2022-03-29
18800020101171POTENZA TipJeisys Medical Inc.C9 Tip2022-03-29
18800020101188POTENZA TipJeisys Medical Inc.I-16 Tip2022-03-29
18800020101195POTENZA TipJeisys Medical Inc.S-16 Tip2022-03-29
18800020101201POTENZA TipJeisys Medical Inc.P1-082022-03-29
B560C20200ZEPTO Precision Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.C20202021-11-23
10607151002074BovieASPEN SURGICAL PRODUCTS, INC.GP3002016-10-13
10607151002319BovieASPEN SURGICAL PRODUCTS, INC.A9502016-10-13
10607151002562BovieASPEN SURGICAL PRODUCTS, INC.A1250U2016-10-13
10607151004368BovieASPEN SURGICAL PRODUCTS, INC.GI1202016-10-13
10607151005037BovieASPEN SURGICAL PRODUCTS, INC.A1250U-LOANER2016-10-13
10607151005358BovieASPEN SURGICAL PRODUCTS, INC.GP300-LOANER2016-10-13
10607151005532BovieASPEN SURGICAL PRODUCTS, INC.GI120-LOANER2016-10-13
10607151005617BovieASPEN SURGICAL PRODUCTS, INC.GI120-DEMO2016-10-13
10607151006805BovieASPEN SURGICAL PRODUCTS, INC.A1250U-V2016-10-13
10607151008014BovieASPEN SURGICAL PRODUCTS, INC.A1250U-V-DEMO2016-10-13
10607151008021BovieASPEN SURGICAL PRODUCTS, INC.A1250U-V-LOANER2016-10-13
10607151008519BovieASPEN SURGICAL PRODUCTS, INC.GP300-DEMO2016-10-13
10607151008533BovieASPEN SURGICAL PRODUCTS, INC.A1250U-VP2016-10-13
10607151009028BovieASPEN SURGICAL PRODUCTS, INC.GP300-REFURBISHED2016-10-13
00749756375146DeRoyalDEROYAL INDUSTRIES, INC.5244Q-T2021-08-05
08886479300214Power Cord 15 ft (US)Aerin Medical Inc.MS11982021-07-15
30749756884038DeRoyalDEROYAL INDUSTRIES, INC.88-002515NS2021-07-12
00841494104917Dual Frequency Footswitch and CableCynosure, LLCDF-FSC#2021-05-25
00841494108403ASSY, Head, Massage, Cellulite, 60mm, TempSureCynosure, LLCASY-127462021-05-25
00841494108410ASSY, Handpiece, 60mm, TempSureCynosure, LLCASY-127452021-05-25
00841494108427ASSY, 60MM Body Accessory Kit, TempSureCynosure, LLCASY-129442021-05-25
00841494108441ASSY, Full Body Kit With 60mm KitCynosure, LLCASY-129432021-05-25
00841494108519FlexSure Medium ApplicatorCynosure, LLCASY-141152021-05-25
00841494108533FlexSure Large ApplicatorCynosure, LLCASY-141142021-05-25
00841494108564FlexSure Interface AdapterCynosure, LLCASY-141162021-05-25
00810026181108SmoothWave RF GeneratorSONIQUENCE, LLCIEC6-IESU1002021-04-07
00810026181115SmoothWave RF GeneratorSONIQUENCE, LLCIEC6-IESU2002021-04-07
08800020100221POTENZA TipJeisys Medical Inc.CP-21 Tip2021-04-02
08800020100238POTENZA TipJeisys Medical Inc.I-49 Tip2021-04-02
08800020100245POTENZA TipJeisys Medical Inc.S-49 Tip2021-04-02
08800020100252POTENZA TipJeisys Medical Inc.I-25 Tip2021-04-02
08800020100269POTENZA TipJeisys Medical Inc.S-25 Tip2021-04-02
08800020100207POTENZA TipJeisys Medical Inc.Combo-box2021-03-29
08800020100214POTENZA DemokitJeisys Medical Inc.Demokit2021-03-29
10850003231591CellFXPulse Biosciences, Inc.FG5003-012021-03-08
10850003231621CellFXPulse Biosciences, Inc.FG5006-01, FG6009-012021-03-08
10850003231652CellFXPulse Biosciences, Inc.FG5012-01, FG6015-012021-03-08
00850003231389CellFXPulse Biosciences, Inc.FG2100-012021-02-26
00850003231419CellFXPulse Biosciences, Inc.FG2250-012021-02-26
10850003231607CellFXPulse Biosciences, Inc.FG5004-012021-02-26
10850003231638CellFXPulse Biosciences, Inc.FG5007-01, FG6010-012021-02-26
10850003231669CellFXPulse Biosciences, Inc.FG5013-01, FG6016-012021-02-26
08800020100191POTENZA TipJeisys Medical Inc.CP-212021-02-27
08809502330170HandpieceVIOL Co.,Ltd.P/B2021-01-14
08809502330187Foot switchVIOL Co.,Ltd.F/S-B2021-01-14
30840143900369Fusion Ablation SystemATRICURE, INC.001-700-001S2021-01-08
30840143900383Fusion Ablation SystemATRICURE, INC.001-700-0032021-01-08
08800020100177INTRAcel RF Microneedle SystemJeisys Medical Inc.INTRAcel PRO2021-01-07
08800020100184INTRAcel RF Microneedle SystemJeisys Medical Inc.INTRAcel2021-01-07
08809502330026CELFIRMVIOL Co.,Ltd.CELFIRM2018-02-23
08809502330033FOOT SWITCHVIOL Co.,Ltd.F/S2018-04-02
08809502330040HAND PIECEVIOL Co.,Ltd.H/S_022018-04-02
08809502330088SCARLET SRFVIOL Co.,Ltd.SCARLET SRF2018-11-19
10607151009769BOVIE ULTIMATEASPEN SURGICAL PRODUCTS, INC.BVX-100H2016-10-13
10607151010123BOVIE ULTIMATEASPEN SURGICAL PRODUCTS, INC.BVX-100H-DEMO2016-10-13
08886479300160VivAer® StylusAerin Medical Inc.FG7222020-10-19
08809502330101SYLFIRM XVIOL Co.,Ltd.SYLFIRM X2020-04-28
00888937013993WALLACHCoopersurgical, Inc.9090752016-08-22