FDA.reportPublic FDA data

Laser lithotripsy system

Definition
An assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). The assembly transmits the laser energy to the stone(s) which fragment. The debris may be removed forcefully or passed out later by natural means.
GUDID devices
193
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810116020003Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron Single Use 2016-09-27
00810116020010Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron Single Use2016-09-27
00810116020034Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 Micron Single Use2016-09-27
00810116020041Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 Micron Reusable2016-09-27
00810116020058Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 Micron Reusable2016-09-27
00810116020065Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron Reusable2016-09-27
00810116020072Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron Reusable2016-09-27
00810116020218Dornier MedTechDORNIER MEDTECH AMERICA, INC.200 Series Single Use2016-09-27
00810116020249Dornier MedTechDORNIER MEDTECH AMERICA, INC.200 Series Reusable2016-09-27
00810116020256Dornier MedTechDORNIER MEDTECH AMERICA, INC.200 Series Flex Single Use2016-12-09
00810116020331Dornier MedTechDORNIER MEDTECH AMERICA, INC.Slim 270 Micron Ball Tip Single Use2018-04-10
00810116020348Dornier MedTechDORNIER MEDTECH AMERICA, INC.Slim 270 Micron Single Use2018-04-10
00810116020355Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron Single Use 2018-04-10
00810116020362Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron Single Use2018-04-10
00810116020379Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 Micron Single Use2018-04-10
00810116020386Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 Micron Single Use2018-04-10
00810116020447Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron Reusable2018-04-10
00810116020454Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron Reusable2018-04-10
00810116020478Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 Micron Reusable2018-04-10
00810116020485Dornier MedTechDORNIER MEDTECH AMERICA, INC.Slim 270 Micron Reusable2018-04-10
00810116020492Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier Medilas H 270 Micron Single Use Laser Fibe2023-06-27
00810116020508Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier Medilas H 400 Micron Single Use Laser Fibe2023-06-27
00810116020515Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier Medilas H 270 Micron Single Use Ball Tip L2023-06-27
00810116022601Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA UroBeam Diode Laser 2023-06-28
00810116022625Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 550 µm Single-Use SMA UroBeam Diode Laser 2023-06-29
00810116022649Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA Diode Laser Fiber wi2023-06-28
00810116022663Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA Diode Laser Fiber wi2023-06-28
00810116022687Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA Diode Laser Fiber wi2023-06-28
00810116022700Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 400 µm Single-Use SMA Diode Laser Fiber 2.2023-06-29
00810116022724Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA Diode Laser Fiber 2.2023-06-29
00810116022748Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 400 µm Single-Use ND YAG Laser Fiber 3.5m2023-06-28
00810116022762Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use ND YAG Laser Fiber 3.5m2023-06-28
00810116023066Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier SingleFlex 200 High Energy Ball Tip Laser 2023-06-28
00810116023141Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 200 High Energy Reusable (5X)2023-06-28
00810116023158Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 270 High Energy Reusable (5X)2023-06-28
00810116023165Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 400 High Energy Reusable (5X)2023-06-28
00810116023172Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 600 High Energy Reusable (5X)2023-06-28
00810116023189Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 1000 High Energy Reusable (5X)2023-06-28
00810116023264Dornier MedTechDORNIER MEDTECH AMERICA, INC.200 Micron SU Thulio High Performance 3m Fiber2023-06-28
00810116023271Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron SU Thulio Slim Performance 3m Fiber2023-06-28
00810116023288Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron SU Thulio Performance 3m Fiber2023-06-28
00810116023295Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron SU Thulio Performance 3m Fiber2023-06-28
00810116023301Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron SU Thulio Performance 4.5m Fiber2023-06-28
00810116023318Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 Micron SU Thulio Performance 3m Fiber2023-06-28
00810116023325Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 Micron SU Thulio Performance 3m Fiber2023-06-28
00810116023332Dornier MedTechDORNIER MEDTECH AMERICA, INC.200 Micron SU Thulio Performance Ball-Tip 3m Fiber2023-06-28
00810116023349Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron SU Thulio Performance Ball-Tip 3m Fiber2023-06-28
00810116023448Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 200µM 3M PERF. FIBER 3ST 10X USE2023-06-28
00810116023455Dornier MedTechDORNIER MEDTECH AMERICA, INC.Holmium 270um 3M Fiber 3ST 10X Use- LATAM Non-RFID2023-06-26
00810116023462Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 270µM 3M SLIM PERF. 3ST 10X USE2023-06-28
00810116023479Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 400µM 3M PERF. FIBER 3ST 10X USE2023-06-28
00810116023486Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 600µM 3M PERF. FIBER 3ST 10X USE2023-06-28
00810116023493Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 1000µM 3M PERF. FIBER 3ST 10X USE2023-06-28
00810116023509Dornier MedTechDORNIER MEDTECH AMERICA, INC.Holmium 400um 3M Fiber 3ST 10X Use - LATAM Non-RFI2023-06-27
04049958003097Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958003103Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958003110Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958003127Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958003134Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958003141Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 micron Holmium Laser Fiber Cable, Single Use,2023-06-29
04049958003158Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Reusable, RF2023-06-29
04049958003165Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Reusable, RF2023-06-29
04049958003172Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron Holmium Laser Fiber Cable, Reusable, RF2023-06-29
04049958003189Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron Holmium Laser Fiber Cable, Reusable, RF2023-06-29
04049958003196Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 micron Holmium Laser Fiber Cable, Reusable, R2023-06-29
04049958003837Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Reusable, Fr2023-06-29
04049958003851Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron Holmium Laser Fiber Cable, Reusable, Fr2023-06-29
04049958003868Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron Holmium Laser Fiber Cable, Reusable, Fr2023-06-29
04049958003875Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 micron Holmium Laser Fiber Cable, Reusable, F2023-06-29
04049958003912Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
B050LF0101X2000FibernexTYPENEX MEDICAL LLCLF0101X2002016-12-22
B050LF0101X2720FibernexTYPENEX MEDICAL LLCLF0101X2722016-12-22
B050LF0101X3650FibernexTYPENEX MEDICAL LLCLF0101X3652016-12-27
B050LF0101X5500FibernexTYPENEX MEDICAL LLCLF0101X5502016-12-27
B050LF0101X9400FibernexTYPENEX MEDICAL LLCLF0101X9402016-12-27
B050LF0201X2000FibernexTYPENEX MEDICAL LLCLF0201X2002016-12-27
B050LF0201X2720FibernexTYPENEX MEDICAL LLCLF0201X2722016-12-27
B050LF0201X3650FibernexTYPENEX MEDICAL LLCLF0201X3652016-12-27
B050LF0201X5500FibernexTYPENEX MEDICAL LLCLF0201X5502016-12-27
B050LF0201X9400FibernexTYPENEX MEDICAL LLCLF0201X9402016-12-27