FDA.reportPublic FDA data

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

Definition
A 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
104
Last updated
2022-09-12 08:34:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07290109147031SlimLine™LUMENIS LTD.Slimline™ EZ SIS 3652022-09-04
07290109147048SlimLine™LUMENIS LTD.Slimline™ EZ SIS 2002022-09-04
07290109145662SlimLine™LUMENIS LTD.SlimLine™ SIS EZ 5502022-07-25
07290109145808Xpeeda™ ENDO D/S/LLUMENIS LTD.Xpeeda™ ENDO D/S/L2022-07-25
EOBN210135S0NAOBERON GmbH Fiber TechnologiesFiber Optic for MRI red2022-03-17
EOBN210136S0NAOBERON GmbH Fiber TechnologiesFiber Optic for MRI yellow2022-03-17
EOBN210137S0NAOBERON GmbH Fiber TechnologiesFiber Optic for MRI green2022-03-17
EOBN210138S0NAOBERON GmbH Fiber TechnologiesFiber Optic for MRI blue2022-03-17
EOBN270122S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber - Radial Emission Fiber 400µm2021-12-23
EOBN270123S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber - Radial Emission Fiber 600µm2021-12-23
EOBN210167S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber 600µm2021-08-16
00810077635711200 TRUE ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0200S-RT-00C-BLK-12021-07-06
00810077635728272 ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0272S-RT-00C-BLK-12021-07-06
00810077635735365 ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0365S-RT-00C-BLK-12021-07-06
00810077635742550 ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0550S-RT-00C-BLK-12021-07-06
008100776357591000 ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-1000S-RT-00C-BLK-12021-07-06
00810077635766200 TRUE Excalibur TorTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0200S-FT-STC-BLK-12021-07-06
00810077635773272 Excalibur ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0272S-FT-STC-BLK-12021-06-29
00810077630426200 ScopeSafe Laser Fiber with ScopeGuardian SheathOPTICAL INTEGRITY INCOI-0200S-FT-SH0-LEX-12021-05-19
00810077630433272 ScopeSafe Laser Fiber with ScopeGuardian SheathOPTICAL INTEGRITY INCOI-0272S-FT-SH0-LEX-12021-05-19
00810077630440300 ScopeSafe Laser Fiber with ScopeGuardian SheathOPTICAL INTEGRITY INCOI-300S-FT-SH0-LEX-12021-05-19
00810077630457200 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0200S-FT-000-LEX-12021-05-19
008100776304641000 Laser FiberOPTICAL INTEGRITY INCOI-1000S-FT-000-LEX-12021-05-19
00810077630471QLASE Side Fire Laser Fiber with Adjustable Stand-Off CatheterOPTICAL INTEGRITY INCOI-0750S-00-000-000-12021-05-19
00810077630488QLASE Adjustable Stand-Off CatheterOPTICAL INTEGRITY INCOI-0750S-SF-CO0-LEX-12021-05-19
00810077630495272 ScopeSafe Laser Fiber with Soft TipOPTICAL INTEGRITY INCOI-0272S-FT-ST0-LEX-12021-05-19
00810077630501200 ScopeSafe Laser Fiber with Soft TipOPTICAL INTEGRITY INCOI-0200S-FT-ST0-LEX-12021-05-19
00810077630198550 Laser FiberOPTICAL INTEGRITY INCOI-0550S-FT-000-BLU-12021-05-18
00810077630204272 ScopeSafe Laser Fiber with Resistive SleeveOPTICAL INTEGRITY INCOI-0272S-FT-000-RES-12021-05-18
00810077630211365 Laser Fiber with Resister SleeveOPTICAL INTEGRITY INCOI-0365S-FT-000-RES-12021-05-18
00810077630228550 Laser Fiber with Resistive SleeveOPTICAL INTEGRITY INCOI-0550S-FT-000-RES-12021-05-18
00810077630235365 Laser Fiber Extended Length (4m)OPTICAL INTEGRITY INCOI-0365S-FT-XL0-BIG-12021-05-18
00810077633274300 ScopeSafe Laser FiberOPTICAL INTEGRITY INCKS-0300S-FT-000-BLU-12021-05-18
00810077633281200 Flex-G Laser Fiber with Extended Length SheathOPTICAL INTEGRITY INCKS-0200S-FT-SH0-BLU-12021-05-18
00810077633298272 Flex-G Laser Fiber with Extended Length SheathOPTICAL INTEGRITY INCKS-0272S-FT-SH0-BLU-12021-05-18
00810077633304300 Flex-G Laser Fiber with Extended Length SheathOPTICAL INTEGRITY INCKS-0300S-FT-SH0-BLU-12021-05-18
00810077633311200 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-0200S-FT-000-LEX-12021-05-18
00810077633328272 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-0272S-FT-000-LEX-12021-05-18
00810077633335365 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-0365S-FT-000-LEX-12021-05-18
00810077633342550 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-0550S-FT-000-LEX-12021-05-18
00810077633359940 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-1000S-FT-000-LEX-12021-05-18
00810077633366200 Flex-G Laser Fiber with Sheath for CalculaseOPTICAL INTEGRITY INCKS-0200S-FT-SC0-LEX-12021-05-18
00810077633373272 Flex-G Laser Fiber with Sheath for CalculaseOPTICAL INTEGRITY INCKS-0272S-FT-SC0-LEX-12021-05-18
00810077633380300 Flex-G Laser Fiber with Sheath for CalculaseOPTICAL INTEGRITY INCKS-0300S-FT-SC0-LEX-12021-05-18
00810077633397200 Flex-G Laser Fiber with SheathOPTICAL INTEGRITY INCKS-0200S-FT-SL0-LEX-12021-05-18
00810077633403272 Flex-G Laser Fiber with SheathOPTICAL INTEGRITY INCKS-0272S-FT-SL0-LEX-12021-05-18
00810077633410300 Flex-G Laser Fiber with SheathOPTICAL INTEGRITY INCKS-0300S-FT-SL0-LEX-12021-05-18
00810077630167365 Laser FiberOPTICAL INTEGRITY INCOI-0365S-FT-000-BLU-12021-05-17
00810077630174272 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0272S-FT-000-BLU-12021-05-17
00810077630181300 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0330S-FT-000-BLU-12021-05-17
00810077633113550 Laser FiberOPTICAL INTEGRITY INCKS-0550S-FT-000-BLU-12021-05-17
00810077633120940 Laser FiberOPTICAL INTEGRITY INCKS-1000S-FT-000-BLU-12021-05-17
04260155592348Laser Surgery Fibers and ProbesA.R.C. Laser GmbHLL28068s2021-05-12
00810077630082200µm ScopeSafe Laser FiberOPTICAL INTEGRITY INCKS-0200S-FT-000-BLU-12021-05-11
00810077630099272 ScopeSafe Laser FiberOPTICAL INTEGRITY INCKS-272S-FT-000-BLU-12021-05-11
00810077630105365 Laser FiberOPTICAL INTEGRITY INCKS-365S-FT-000-BLU-12021-05-11
00810077632017200 Excalibur Laser FiberOPTICAL INTEGRITY INCFT-0200S-FT-STO-FOR-22021-05-11
00810077632024272 Excalibur Laser FiberOPTICAL INTEGRITY INCFT-0272S-FT-STO-FOR-12021-05-11
00850013050154SureGuideClinicon Corporation40342021-05-06
00850013050161SureGuideClinicon Corporation41402021-05-06
00850013050178SureGuideClinicon Corporation31562021-05-06
00850013050185SureGuideClinicon Corporation41432021-05-06
00850013050000SureProbeClinicon Corporation40002021-05-05
00850013050017SureProbeClinicon Corporation40012021-05-05
00850013050024SureProbeClinicon Corporation40022021-05-05
00850013050031SureProbeClinicon Corporation40072021-05-05
00850013050048SureProbeClinicon Corporation40032021-05-05
00850013050055SureProbeClinicon Corporation40082021-05-05
00850013050062SureProbeClinicon Corporation40042021-05-05
00850013050079SureProbeClinicon Corporation41592021-05-05
00850013050086SureProbeClinicon Corporation41492021-05-05
00850013050093SureProbeClinicon Corporation40112021-05-05
00850013050116SureTouchClinicon Corporation40122021-05-05
00850013050123SureTipClinicon Corporation37282021-05-05
00810077630051550 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0550S-FT-000-BIG-12021-04-13
00810077633014272 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0272S-FT-000-BIG-12021-04-13
00810077633021300 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0300S-FT-000-BIG-12021-04-13
00810077633038200 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0200S-FT-000-BIG-12021-04-13
00810077633045365 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0365S-FT-000-BIG-12021-04-13
008100776330691000 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-1000S-FT-000-BIG-12021-04-13