FDA.reportPublic FDA data

General/multiple surgical diode laser system

Definition
A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.
GUDID devices
158
Last updated
2021-03-18 09:14:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00813125016654IRIDEX 810 LaserIRIDEX CORPORATION220002021-03-10
00763000416454VisualaseMEDTRONIC NAVIGATION, INC.97355662021-02-21
00763000402099VisualaseMEDTRONIC NAVIGATION, INC.97363172021-01-29
00763000255954VisualaseMEDTRONIC NAVIGATION, INC.97355712021-01-14
00763000416461VisualaseMEDTRONIC NAVIGATION, INC.97355712021-01-14
08059173390700Opera EvoQUANTA SYSTEM SPAPDMS002542020-11-28
04260155592553Diode Laser Wolf 445nmA.R.C. Laser GmbHLS110002020-07-09
00643169981836StealthStationMEDTRONIC NAVIGATION, INC.97359792020-07-02
00763000313364VisualaseMEDTRONIC NAVIGATION, INC.97355422020-06-27
00763000357504VisualaseMEDTRONIC NAVIGATION, INC.97363172020-05-17
02816901021758NALEONI FIBER OPTICS, INC.NV06152019-03-01
00763000218188VisualaseMEDTRONIC NAVIGATION, INC.97355602019-03-18
08057017760504ECHOLASER X4EL.EN. SPAM095G12020-02-14
08057017760320ECHOLASER X4EL.EN. SPAM095D12020-01-15
06970745918905ApolomedShanghai Apolo Medical Technology Co.,LtdHS-890A2020-01-06
04260155593017Diode laser FOX 1064 nm.A.R.C. Laser GmbHLS032002019-11-19
00643169933392VisualaseMEDTRONIC NAVIGATION, INC.97355662019-07-04
04260155590078Diode laser FOX 980 nm.A.R.C. Laser GmbHLS032002019-05-08
00763000218195VisualaseMEDTRONIC NAVIGATION, INC.97355612019-04-29
17290110121300Alma VascuLife Diode System 1470 110VALMA LASERS LTD.12016-09-24
17290110121317Alma LipoDiode System 1470 110VALMA LASERS LTD.12016-09-24
17290110121324"""Alma LipoLife System 110-120V """ALMA LASERS LTD.12016-09-24
17340007000017Mobile Laser UnitClinical Laserthermia Systems AB1001-012016-09-18
17340007000024Tissue Temp ProbeClinical Laserthermia Systems AB3101-012016-09-18
17340007000031Tissue Temp ProbeClinical Laserthermia Systems AB3101-022016-09-18
17340007000048Tissue Temp ProbeClinical Laserthermia Systems AB3201-012016-09-18
17340007000055Tissue Temp ProbeClinical Laserthermia Systems AB3102-012016-09-18
17340007000062Tissue Temp ProbeClinical Laserthermia Systems AB3102-022016-09-18
17340007000079Tissue Temp ProbeClinical Laserthermia Systems AB3202-012016-09-18
17340007000086Tissue Temp ProbeClinical Laserthermia Systems AB3103-012016-09-18
17340007000093Tissue Temp ProbeClinical Laserthermia Systems AB3103-022016-09-18
17340007000109Tissue Temp ProbeClinical Laserthermia Systems AB3203-012016-09-18
17340007000130Mains Cable USClinical Laserthermia Systems AB4001-032016-09-18
17340007000147Protection GogglesClinical Laserthermia Systems AB4002-012016-09-18
17340007000154Laser Warning SignClinical Laserthermia Systems AB4003-012016-09-18
17340007000161TrolleyClinical Laserthermia Systems AB4009-012016-09-18
17340007000390Thermal Therapy System Instructions for UseClinical Laserthermia Systems ABL-2016-051EN2016-09-18
17340007000543Foot PedalClinical Laserthermia Systems AB4018-012017-08-16
00763000218171VisualaseMEDTRONIC NAVIGATION, INC.97355592019-03-21
04049958000218Dornier MedTechDornier MedTech GmbHMedilas D LiteBeam+ (D-Plug)2018-09-11
04049958000225Dornier MedTechDornier MedTech GmbHMedilas D MultiBeam (D-Plug)2018-09-11
04049958001307Dornier MedTechDornier MedTech GmbHMedilas D FlexiPulse (D-Plug)2018-09-11
04049958001383Dornier MedTechDornier MedTech GmbHMedilas D MultiBeam (D-Plug)2018-09-13
04049958002090Dornier MedTechDornier MedTech GmbHMedilas D30 1064 (SMA)2018-09-12
04049958002229Dornier MedTechDornier MedTech GmbHMedilas D LiteBeam+ (1470 SMA)2018-09-13
04049958002441Dornier MedTechDornier MedTech GmbHMedilas D LiteBeam+ (1470 D-Plug)2018-09-11
04058784000026QuardoStar PROAsclepion Laser Technologies GmbH14902016-09-17
04058784000033QuadroStar PROAsclepion Laser Technologies GmbH14912016-09-17
04058784000057QuardoStar PROAsclepion Laser Technologies GmbH14932016-09-17
04059497000273CoolLipoTMLEONI Fiber Optics GmbHCL 320 S2016-09-29
04059497000747CoolLipoTMLEONI Fiber Optics GmbHCL 500 S2016-09-29
06970285174168Powered Laser Surgical Instrument-Diode Laser ModelBeijing Syntech Laser Co., Ltd.DLH-062017-06-29
06970285174281Powered Laser Surgical Instrument-Diode LaserBeijing Syntech Laser Co., Ltd.DLH-122018-07-12
06970460900001GIGAAWuhan Gigaa Optronics Technology Co.,Ltd.VELASⅡ-15D2018-09-14
06970460900018GIGAAWuhan Gigaa Optronics Technology Co.,Ltd.GBOX-15A2016-09-26
06970460900025GIGAAWuhan Gigaa Optronics Technology Co.,Ltd.GBOX-15B2016-09-26
06970460900032GIGAAWuhan Gigaa Optronics Technology Co.,Ltd.VELASⅡ-30A2016-09-26
06970460900049GIGAAWuhan Gigaa Optronics Technology Co.,Ltd.VELASⅡ-30B2016-09-26
06970460900056GIGAAWuhan Gigaa Optronics Technology Co.,Ltd.VELASⅡ-60A2016-09-26
06970460900063GIGAAWuhan Gigaa Optronics Technology Co.,Ltd.VELASⅡ-60B2016-09-26
06970460900070GIGAAWuhan Gigaa Optronics Technology Co.,Ltd.VELASⅡ-60C2016-09-26
07290016629019neoVG.N.S NEOLASER LTDneoV9802016-09-01
07290016629026neoVG.N.S NEOLASER LTDneoV9802016-09-01
07290016629040neoVG.N.S NEOLASER LTDneoV8102016-09-01
07290016629057neoVG.N.S NEOLASER LTDneoV8102016-09-01
07290016629064neoVG.N.S NEOLASER LTDNeoV10642016-09-01
07290016629071neoVG.N.S NEOLASER LTDneoV10642016-09-01
07290016629088neoVG.N.S NEOLASER LTDNeoV10642016-09-01
07290016629095neoVG.N.S NEOLASER LTDneoV10642016-09-01
07290016629101neoVG.N.S NEOLASER LTDneoV14702016-09-01
07290016629118neoVG.N.S NEOLASER LTDneoV14702016-09-01
07290016629125neoVG.N.S NEOLASER LTDneoV14702016-09-01
07290016629132neoVG.N.S NEOLASER LTDneoV14702016-09-01
07290016629149neoVG.N.S NEOLASER LTDneoV9802016-09-01
07290016629170neoVG.N.S NEOLASER LTDneoV9802016-09-01
00872320003364Pilot Diode Laser 600um TipCAO GROUP, INC.030932016-11-10
00872320003418Pilot Straight TipCAO GROUP, INC.006682016-11-10
00872320003425Pilot 60° TipCAO GROUP, INC.006692016-11-10
00872320003456Pilot Diode LaserCAO GROUP, INC.030922016-11-10
01816901020448NALEONI FIBER OPTICS, INC.NV06322016-10-05