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; a fibreoptic cable may be included with the device. This is a single-use device.
GUDID devices
310
Last updated
2026-08-28 10:19:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04053002150316Bare Fiber 400 T Luer LockLight Guide Optics International SIALGO-Bare Fiber Single Use2026-08-14
04053002150415Bare Fiber 600 T Luer LockLight Guide Optics International SIALGO-Bare Fiber Single Use2026-08-14
04053002150514CORONA 360 Fused 600 1.8 USLight Guide Optics International SIALGO-Saturn Side Fiber2026-08-14
04053002150613CORONA Infinite Ring XSCF 600 1.6 USLight Guide Optics International SIALGO-Infinity Side Fiber2026-08-14
04053002150712Rigid Infinite Ring HSC Probe 600 1.8 USLight Guide Optics International SIALGO-Infinity Hemorrhoid Probe2026-08-14
EOBN210188S0NAOBERON GmbH Fiber TechnologiesLaser Surgery Fiber 272µm2026-07-22
06976712970297Hemolase FiberMicro-Energy Medical Technology Co., LtdHemo-R-0.40-2.52026-07-13
06976712970303Hemolase FiberMicro-Energy Medical Technology Co., LtdHemo-R-0.60-2.52026-07-13
06976712970310Hemolase FiberMicro-Energy Medical Technology Co., LtdHemo-R-0.40-1.82026-07-13
06976712970327Hemolase FiberMicro-Energy Medical Technology Co., LtdHemo-R-0.60-1.82026-07-13
00860007603785Sentient ManufacturingSentient Manufacturing, LLC30411402022-09-16
00801741122194EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU02002016-08-22
00801741122200EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU02722016-08-22
00801741122217EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU03652016-08-22
00801741122224EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU05502016-08-22
00801741122231EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU10002016-08-22
00801741122644EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU0200EL2016-08-22
00801741122651EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU0272EL2016-08-22
00801741122668EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU0365EL2016-08-22
00801741122675EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU0550EL2016-08-22
00801741122682EndoBeam™ Holmium Laser FiberC. R. Bard, Inc.SU1000EL2016-08-22
00810077630013272 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0272S-FT-000-BIG-12021-04-13
00810077630020300 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0300S-FT-000-BIG-12021-04-13
00810077630037200 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0200S-FT-000-BIG-12021-04-13
00810077630044365 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-0365S-FT-000-BIG-12021-04-13
008100776300681000 ScopeSafe Laser FiberOPTICAL INTEGRITY INCOI-1000S-FT-000-BIG-12021-04-13
00810077630112550 Laser FiberOPTICAL INTEGRITY INCKS-0550S-FT-000-BLU-12021-05-17
00810077630129940 Laser FiberOPTICAL INTEGRITY INCKS-1000S-FT-000-BLU-12021-05-17
00810077630273300 ScopeSafe Laser FiberOPTICAL INTEGRITY INCKS-0300S-FT-000-BLU-12021-05-18
00810077630280200 Flex-G Laser Fiber with Extended Length SheathOPTICAL INTEGRITY INCKS-0200S-FT-SH0-BLU-12021-05-18
00810077630297272 Flex-G Laser Fiber with Extended Length SheathOPTICAL INTEGRITY INCKS-0272S-FT-SH0-BLU-12021-05-18
00810077630303300 Flex-G Laser Fiber with Extended Length SheathOPTICAL INTEGRITY INCKS-0300S-FT-SH0-BLU-12021-05-18
00810077630310200 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-0200S-FT-000-LEX-12021-05-18
00810077630327272 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-0272S-FT-000-LEX-12021-05-18
00810077630334365 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-0365S-FT-000-LEX-12021-05-18
00810077630341550 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-0550S-FT-000-LEX-12021-05-18
00810077630358940 ScopeSafe Laser Fiber for CalculaseOPTICAL INTEGRITY INCKS-1000S-FT-000-LEX-12021-05-18
00810077630365200 Flex-G Laser Fiber with Sheath for CalculaseOPTICAL INTEGRITY INCKS-0200S-FT-SC0-LEX-12021-05-18
00810077630372272 Flex-G Laser Fiber with Sheath for CalculaseOPTICAL INTEGRITY INCKS-0272S-FT-SC0-LEX-12021-05-18
00810077630389300 Flex-G Laser Fiber with Sheath for CalculaseOPTICAL INTEGRITY INCKS-0300S-FT-SC0-LEX-12021-05-18
00810077630396200 Flex-G Laser Fiber with SheathOPTICAL INTEGRITY INCKS-0200S-FT-SL0-LEX-12021-05-18
00810077630402272 Flex-G Laser Fiber with SheathOPTICAL INTEGRITY INCKS-0272S-FT-SL0-LEX-12021-05-18
00810077630419300 Flex-G Laser Fiber with SheathOPTICAL INTEGRITY INCKS-0300S-FT-SL0-LEX-12021-05-18
00810077630563200 Excalibur Laser FiberOPTICAL INTEGRITY INCFT-0200S-FT-STO-FOR-22021-05-11
00810077630570272 Excalibur Laser FiberOPTICAL INTEGRITY INCFT-0272S-FT-STO-FOR-12021-05-11
00810077630716200 TRUE ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0200S-RT-00C-BLK-12021-07-06
00810077630723272 ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0272S-RT-00C-BLK-12021-07-06
00810077630730365 ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0365S-RT-00C-BLK-12021-07-06
00810077630747550 ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0550S-RT-00C-BLK-12021-07-06
008100776307541000 ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-1000S-RT-00C-BLK-12021-07-06
00810077630761200 TRUE Excalibur TorTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0200S-FT-STC-BLK-12021-07-06
00810077630778272 Excalibur ForTec Thulium TFL Laser FiberOPTICAL INTEGRITY INCFT-0272S-FT-STC-BLK-12021-06-29
00810077631294SmartScopeOPTICAL INTEGRITY INCSU-200-RT2024-03-22
00810077631300SmartScopeOPTICAL INTEGRITY INCSU-365-RT2024-03-22
00810077631317SmartScopeOPTICAL INTEGRITY INCSU-550-RT2024-03-22
00810077631324SmartScopeOPTICAL INTEGRITY INCSU-1000-RT2024-03-22
00810077631331SmartScopeOPTICAL INTEGRITY INCSU-200-TRUE-RT2024-03-22
00810077631379300 micron laser fiber (KTP)OPTICAL INTEGRITY INC119112024-09-06
00810077631409300 micron laser fiber (KTP) with ScopeGuardian sheathOPTICAL INTEGRITY INC119402024-09-24
00810116020751Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron Single Use HE2019-10-16
00810116020768Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 Micron Single Use HE2019-10-16
00810116020775Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 Micron Single Use HE2019-10-16
00810116022380Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron single use luer lock 2019-10-16
00810116022403Dornier MedTechDORNIER MEDTECH AMERICA, INC.365 micron single use luer lock 2019-10-16
00810116022427Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron single use luer lock 2019-10-16
00810116022526Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron single use luer lock 2019-10-16
00810116022540Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron single use luer lock 2019-10-16
00810116022588Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron single use SMA2019-10-16
00821925043886SOLTIVEGyrus ACMI, LLCTFL-FBX150S2024-07-25
00821925043923SOLTIVEGyrus ACMI, LLCTFL-FBX150BS2024-08-01
00821925043947SOLTIVEGyrus ACMI, LLCTFL-FBX200S2024-08-01
00821925043985SOLTIVEGyrus ACMI, LLCTFL-FBX200BS2024-08-01
00821925044005SOLTIVEGyrus ACMI, LLCTFL-FBX365S2024-08-01
00821925044043SOLTIVEGyrus ACMI, LLCTFL-FBX550S2020-05-07
00821925044081SOLTIVEGyrus ACMI, LLCTFL-FBX940S2024-08-01
00821925045378OlympusGyrus ACMI, LLCTFL-FBX150BSE2024-10-09
00821925045392OlympusGyrus ACMI, LLCTFL-FBX150SE2024-10-09
00821925045415OlympusGyrus ACMI, LLCTFL-FBX200BSE2024-10-09
00821925045453OlympusGyrus ACMI, LLCTFL-FBX365SE2024-10-09
00821925045477OlympusGyrus ACMI, LLCTFL-FBX550SE2024-10-09