FDA.reportPublic FDA data

General/multiple surgical laser system beam guide, single-use, sterile

Definition
A sterile, surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a single-use device.
GUDID devices
165
Last updated
2020-08-28 06:22:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04260155591983Laser Surgery Fibers and ProbesA.R.C. Laser GmbHLL28066s2020-08-20
04260155592126Laser Surgery Fibers and ProbesA.R.C. Laser GmbHLL13062s2020-08-20
04260155592256Laser Surgery Fibers and ProbesA.R.C. Laser GmbHLL28062s2020-08-20
04260155592287Laser Surgery Fibers and ProbesA.R.C. Laser GmbHLL13066s2020-08-20
B145116110Excalibur 200 TRUE micrometer laser fiberOPTICAL INTEGRITY INCSU-200-TRUE-EX2020-07-13
EOBN200029S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber 600µm 2.6m2017-06-09
EOBN210110S0NAOBERON GmbH Fiber TechnologiesFiber Optic for PLA Short red2019-01-15
EOBN210111S0NAOBERON GmbH Fiber TechnologiesFiber Optic for PLA Short yellow2019-01-15
EOBN210112S0NAOBERON GmbH Fiber TechnologiesFiber Optic for PLA Short green2019-01-15
EOBN210113S0NAOBERON GmbH Fiber TechnologiesFiber Optic for PLA Short blue2019-01-15
EOBN210114S0NAOBERON GmbH Fiber TechnologiesFiber Optic for PLA Long red2019-01-15
EOBN210115S0NAOBERON GmbH Fiber TechnologiesFiber Optic for PLA Long yellow2019-01-15
EOBN210116S0NAOBERON GmbH Fiber TechnologiesFiber Optic for PLA Long green2019-01-15
EOBN210117S0NAOBERON GmbH Fiber TechnologiesFiber Optic for PLA Long blue2019-01-15
EOBN230051N0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber - Dental Bare Fiber 200µm2019-01-24
EOBN230052N0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber - Dental Bare Fiber 320µm2019-01-24
EOBN230053S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber - Chirurgie Bare Fiber 320µm2019-01-24
EOBN270055S0NAOBERON GmbH Fiber TechnologiesRadial Emission Fiber 400µm2017-02-18
EOBN270117S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber - Radial Emission Fiber 400µm 2019-01-15
EOBN270118S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber - Radial Emission Fiber 400µm 2019-01-15
EOBN270119S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber - Radial Emission Fiber 600µm 2019-01-15
EOBN270120S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber - Radial Emission Fiber 600µm 2019-01-15
00855430006685OptiliteConvergent Laser TechnologiesHMA-1010FI2019-12-23
00855430006692OptiliteConvergent Laser TechnologiesHMA-1020FI2019-12-23
00855430006708OptiliteConvergent Laser TechnologiesHMA-1040FI2019-12-23
00855430006715OptiliteConvergent Laser TechnologiesHMA-1060FI2019-12-23
M473203020Trimedyne® Ho:YAG Straightfire™ 25 cm Laser NeedleTRIMEDYNE, INC.203022018-07-11
M47320362SMA0Trimedyne® Ho:YAG Side Firing 29 cm Laser Needle (SMA Connector)TRIMEDYNE, INC.20362-SMA2018-07-11
M47320371HP0Trimedyne® OmniTip™ - 30 cm Side Firing Switchable Tip with Suction/IrrigationTRIMEDYNE, INC.20371-HP2018-07-11
M47320373HP0Trimedyne® OmniTip™ - 35 cm Side Firing Switchable Tip with IrrigationTRIMEDYNE, INC.20373-HP2018-07-11
M47320409SMA0Trimedyne® Ho:YAG Tapertip™ - Side Firing (SMA Connector)TRIMEDYNE, INC.20409-SMA2018-07-11
M473204400Trimedyne® VaporMax® - Ho:YAG Side Firing HandpieceTRIMEDYNE, INC.204402018-07-11
M47320440SMA0Trimedyne® VaporMax® - Ho:YAG Side Firing HandpieceTRIMEDYNE, INC.20440-SMA2018-07-11
M473204420Trimedyne® VaporMax® - Ho:YAG Side Firing HandpieceTRIMEDYNE, INC.204422018-07-11
M47320442SMA0Trimedyne® VaporMax® - Ho:YAG Side Firing HandpieceTRIMEDYNE, INC.20442-SMA2018-07-11
M473204440Trimedyne® VaporMAX® - Ho:YAG Side Firing Fiber-Optic InstrumentTRIMEDYNE, INC.204442018-07-11
M47320444SMA0Trimedyne® VaporMax® - Ho:YAG Side Firing Fiber-Optic InstrumentTRIMEDYNE, INC.20444-SMA2018-07-11
M47320462HP1Trimedyne® OmniTip™ 25 cm Side Firing Laser NeedleTRIMEDYNE, INC.20462-HP2018-07-11
M47320474HP1Trimedyne® OmniTip™ Switchable Tip - StraightTRIMEDYNE, INC.20474-HP2018-07-11
M47320475HP1Trimedyne® OmniTip™ Switchable Tip - 20°TRIMEDYNE, INC.20475-HP2018-07-11
M47320476HP1Trimedyne® OmniTip™ Switchable Tip - 30°TRIMEDYNE, INC.20476-HP2018-07-11
M47320478HP1Trimedyne® OmniTip™ Switchable Tip - 60°TRIMEDYNE, INC.20478-HP2018-07-11
M47320479HP1Trimedyne® OmniTip™ Switchable Tip - Side FiringTRIMEDYNE, INC.20479-HP2018-07-11
M47320489HP1Trimedyne® OmniTip™ Mini Side Firing (90°) Switchable TipTRIMEDYNE, INC.20489-HP2018-07-11
M47320495HP1Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm StraightTRIMEDYNE, INC.20495-HP2018-07-11
M47320496HP1Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Side FiringTRIMEDYNE, INC.20496-HP2018-07-11
M47320497HP1Trimedyne® OmniTip™ Switchable Tip - SJ-50 mm StraightTRIMEDYNE, INC.20497-HP2018-07-11
M473205030Trimedyne® Gas-Cooled 600 µm Fiber with Nozzle Tip (SMA Connector)TRIMEDYNE, INC.205032018-07-11
M473S10001Trimedyne® FlexMax® 1000 µm Single Use Holmium FiberTRIMEDYNE, INC.S10002018-07-11
M473S1000SMA1Trimedyne® FlexMax® 1000 µm Single Use Fiber (SMA Connector)TRIMEDYNE, INC.S1000SMA2018-07-11
M473S2001Trimedyne® FlexMax® 200 µm Single Use Holmium Bare FiberTRIMEDYNE, INC.S2002018-07-11
M473S200SMA1Trimedyne® FlexMax® 200 µm Single Use Holmium Fiber (SMA Connector)TRIMEDYNE, INC.S200SMA2018-07-11
M473S2721Trimedyne® FlexMax® 272 µm Single Use Holmium Bare FiberTRIMEDYNE, INC.S2722018-07-11
M473S272SMA1Trimedyne® FlexMax® 272 µm Single Use Holmium Fiber (SMA Connector)TRIMEDYNE, INC.S272SMA2018-07-11
M473S3651Trimedyne® FlexMax® 365 µm Single Use Holmium Bare FiberTRIMEDYNE, INC.S3652018-07-11
M473S365SMA1Trimedyne® FlexMax® 365 µm Single Use Holmium Fiber (SMA Connector)TRIMEDYNE, INC.S365SMA2018-07-11
M473S55001Trimedyne® FlexMax® 550 µm Single Use Holmium FiberTRIMEDYNE, INC.S5502018-07-11
M473S550SMA1Trimedyne® FlexMax® 550 µm Single Use Fiber (SMA Connector)TRIMEDYNE, INC.S550SMA2018-07-11
M473SF6000100 Watt Holmium Side Fire FiberTRIMEDYNE, INC.SF-6002018-07-11
00810116020720Dornier MedTechDORNIER MEDTECH AMERICA, INC.200 Micron Ball Tip Single Use HE2019-10-16
00810116020737Dornier MedTechDORNIER MEDTECH AMERICA, INC.200 Micron Single Use HE2019-10-16
00810116020744Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron Single Use HE2019-10-16
00810116020812Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron Single Use HE2019-10-16
00810116020829Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 Micron Single Use HE2019-10-16
00810116020836Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 Micron Single Use HE2019-10-16
00810116022397Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron single use luer lock 2019-10-16
00810116022410Dornier MedTechDORNIER MEDTECH AMERICA, INC.365 micron single use luer lock 2019-10-16
00810116022434Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron single use luer lock 2019-10-16
00810116022441Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron slim single use luer lock 2019-10-16
00810116022533Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron single use luer lock 2019-10-16
00810116022557Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron single use luer lock 2019-10-16
00810116022564Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron single use SMA2019-10-16
00810116022595Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron single use SMA2019-10-16
04049089100245Radial-Emitting Shaped Fiber Optic Delivery SystemCeram Optec SIAELVeS® Radial® Fiber 600um, 6F, ID (1x2h)2017-03-07
04049089100252Radial-Emitting Shaped Fiber Optic Delivery SystemCeram Optec SIAELVeS® Radial® Slim Fiber 400um, 4F, ID (1x2h)2017-03-07
04049089300300MegaBeam® Endo-ENT ProbeCeram Optec SIAMegaBeam® Endo-ENT Probe, 24Ga, COH-G, noID2017-03-07
04049089300317MegaBeam® Endo-ENT ProbeCeram Optec SIAMegaBeam® Endo-ENT Probe, 24Ga, COH-H, noID2017-03-07
04049089300324MegaBeam® Endo-ENT ProbeCeram Optec SIAMegaBeam® Endo-ENT Probe, 24Ga, COH-S, noID2017-03-07
04049089300331MegaBeam® Endo-ENT ProbeCeram Optec SIAMegaBeam® Endo-ENT Probe, 24Ga, HGM-G, noID2017-03-07
04049089300348MegaBeam® Endo-ENT ProbeCeram Optec SIAMegaBeam® Endo-ENT Probe, 24Ga, HGM-H, noID2017-03-07