FDA.report

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 inert gas-enhanced electrosurgery.
GUDID devices
275
Last updated
2026-03-24 18:18:46

Related Product Codes

CodeDeviceSpecialtyClassDevices
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2173
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology273
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology212
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology27
OUHSkin Resurfacing Rf ApplicatorGeneral, Plastic Surgery24
EKZUnit, Electrosurgical, And Accessories, DentalDental23
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental11
OABLow Energy Direct Current Thermal Ablation SystemGeneral, Plastic Surgery21
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
08800020101525POTENZAJeisys Medical Inc.Neutral Electrode Pad Cable2026-03-16
08800020108395POTENZAJeisys Medical Inc.Foot Switch2026-03-16
08800020108401POTENZAJeisys Medical Inc.Power Cable2026-03-16
08800020108425POTENZAJeisys Medical Inc.Handpiece Stand2026-03-16
08800020107299POTENZA TipJeisys Medical Inc.Diamond Tip2026-03-10
0880970938047310THERMA / XTHERMATENTECH Inc.TIP TMET0.25-300/ XMET0.25-3002026-02-27
0880970938048010THERMA / XTHERMATENTECH Inc.TIP TMET0.25-600/ XMET0.25-6002026-02-27
0880970938049710THERMA / XTHERMATENTECH Inc.TIP TMFT4.0-300/ XMFT4.0-3002026-02-27
0880970938050310THERMA / XTHERMATENTECH Inc.TIP TMFT4.0-600/ XMFT4.0-6002026-02-27
0880970938051010THERMA / XTHERMATENTECH Inc.TIP TMFT4.0-900/ XMFT4.0-9002026-02-27
0880970938052710THERMA / XTHERMATENTECH Inc.TIP TMFT5.0-300/ XMFT5.0-3002026-02-27
0880970938053410THERMA / XTHERMATENTECH Inc.TIP TMFT5.0-600/ XMFT5.0-6002026-02-27
0880970938054110THERMA / XTHERMATENTECH Inc.TIP TMFT5.0-900/ XMFT5.0-9002026-02-27
0880970938055810THERMA / XTHERMATENTECH Inc.TIP TMBT20.0-500/ XMBT20.0-5002026-02-27
0880970938056510THERMA / XTHERMATENTECH Inc.TIP TMBT20.0-1000/ XMBT20.0-10002026-02-27
00850079280113Ergo glideHexa DentalTurbo-AP2026-01-21
08800020102836JRF-Pad-01Jeisys Medical Inc.JRF-Pad-012025-12-10
08886479300306RhinAer+ StylusAerin Medical Inc.FG22582025-09-19
08809502330422SCARLET PROVIOL Co.,Ltd.SCARLET PRO2025-07-11
08809502330439FOOT SWITCHVIOL Co.,Ltd.F/S-HRF-BLUE2025-07-11
08809502330446HAND PIECEVIOL Co.,Ltd.H/S_032025-07-11
08800016905069QUADESSY Deeplus hand pieceCLASSYS Inc.QD1-M4002025-07-02
08800016905076QUADESSY Smartcure(Basic) hand pieceCLASSYS Inc.QD1-M4002025-07-02
08800016905175QUADESSY Wavplus hand pieceCLASSYS Inc.QD1-M4002025-07-02
08800016905182QUADESSY Neutral hand pieceCLASSYS Inc.QD1-M4002025-07-02
06971782588007Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.Unicorn+2025-06-13
06971782588014Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.Unicorn+ I2025-06-13
06971782588021Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.Unicorn+ II2025-06-13
06971782588038Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.Unicorn+ III2025-06-13
05391537940187NEUROMARK SystemNEURENT MEDICAL LIMITEDNMK003012025-06-02
08800042703059ArtiSeal Vessel Sealing System - ArtiSeal InstrumentsLIVSMEDAS01L2025-05-21
08800042703066ArtiSeal Vessel Sealing System - ArtiSeal GeneratorLIVSMEDASG-10002025-05-21
08800020106308POTENZA TipJeisys Medical Inc.SFA Tip2025-05-19
18800020105506POTENZA TipJeisys Medical Inc.CP-252025-05-19
18800020105612POTENZA TipJeisys Medical Inc.CP-162025-05-19
18800020105629POTENZA TipJeisys Medical Inc.CP-492025-05-19
18800020106299POTENZA TipJeisys Medical Inc.DDR Tip2025-05-19
18800020106312POTENZA TipJeisys Medical Inc.DIA Tip2025-05-19
04250337118312Vaporace®/Vaporgrip® Kabel, L 3,0 mJoimax GmbHVBFC80302025-02-14
04250337118619Vaporace® Probe bipolar, Area 270 mm – 3.5 mmJoimax GmbHJVAPA270352025-02-14
04250337118640Vaporace® Probe bipolar, Area 320 mm – 3.5 mmJoimax GmbHJVAPA320352025-02-14
04250337118978Vaporace® Hand Piece, bipolarJoimax GmbHJVAH100102025-02-14
04250337120230Vaporace® Probe bipolar, Area 150 mm – 3.5 mmJoimax GmbHJVAPA150352025-02-14
00821925038622Gyrus ACMIGyrus ACMI, LLCRKA-42024-12-17
08886479300283Aerin ConsoleAerin Medical Inc.FG20452024-12-18
08886479300290Aerin Console SetAerin Medical Inc.FG20452024-12-18
08809502330286CELLINEW Foot switchVIOL Co.,Ltd.CELLINEW Foot Switch2024-12-09
08809502330347CELLINEWVIOL Co.,Ltd.CELLINEW2024-12-09
08809502330361CELLINEW HandpieceVIOL Co.,Ltd.CELLINEW Handpiece2024-12-09
08809502330378CELLINEW TIPVIOL Co.,Ltd.CF402024-12-09
08809502330385CELLINEW TIPVIOL Co.,Ltd.CE252024-12-09
08800016904741AcuTronCLASSYS Inc.MOR-C12024-10-30
08800016904758AcuTron Main UnitCLASSYS Inc.MOR-C12024-10-30
08800016904765AcuTron HandpieceCLASSYS Inc.MOR-C12024-10-30
00192896120358MICTEC Hook ElectrodeSONTEC INSTRUMENTS, INC.27948-202024-10-17
00887482188873BovieSYMMETRY SURGICAL INC.A23502024-09-27
00887482188897BovieSYMMETRY SURGICAL INC.A33502024-09-27
00887482181324BovieSYMMETRY SURGICAL INC.IDS-2102024-08-26
00887482181508BovieSYMMETRY SURGICAL INC.IDS-3102024-08-26
00887482182536BovieSYMMETRY SURGICAL INC.A9422024-08-26
00887482182550BovieSYMMETRY SURGICAL INC.A9522024-08-26
00821925010819Gyrus ACMIGyrus Acmi, Inc.7035-30062024-07-25
00821925010567Gyrus ACMIGyrus Acmi, Inc.39992024-07-24
08800016213027SILKROHironic Co., ltd.SILKRO2024-06-28
0880970938034310THERMATENTECH Inc.TMSY022024-06-28
0880970938035010THERMATENTECH Inc.TMHP022024-06-28
08809495931071FIXER DV9Chungwoo Co., Ltd.CWM-930S2024-06-25
08809495931088ELLISYS SENSEChungwoo Co., Ltd.CWM-930S2024-06-25
08809495931095APOLEX TiteChungwoo Co., Ltd.CWM-910T2024-06-25
08809495931156RetractionChungwoo Co., Ltd.CWM-910T2024-06-25
08809709380459XTHERMATENTECH Inc.XTHERMA-Body2024-06-25
08809709380466XTHERMATENTECH Inc.XTHERMA-H/P2024-06-25
B413XL1000CP0US Medical InnovationsUS MEDICAL INNOVATIONS, LLCXL-1000CP2024-06-24
00840118606660ENDURE INDUSTRIESENDURE INDUSTRIESCBP150A82024-04-10
00840118606684ENDURE INDUSTRIESENDURE INDUSTRIESCB70A82024-04-10
00840118606707ENDURE INDUSTRIESENDURE INDUSTRIESCBTA82024-04-10
04063763186707DUFNER Instrumente GmbHDUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik26944-022024-03-11
04063763186714DUFNER Instrumente GmbHDUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik26944-032024-03-11
04063763200632DUFNER Instrumente GmbHDUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik20945-012024-03-11
04063763200649DUFNER Instrumente GmbHDUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik20945-032024-03-11