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
103
Last updated
2025-01-15 14:15:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06976812430158Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.UroFiber 60Q2025-01-07
00810116022632Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 550 µm Single-Use SMA UroBeam Diode Laser 2023-06-29
00810116022717Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 400 µm Single-Use SMA Diode Laser Fiber 2.2023-06-29
00810116022731Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA Diode Laser Fiber 2.2023-06-29
04049958002632Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958002649Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958002656Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958002663Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 micron Holmium Laser Fiber Cable, Single Use,2023-06-29
04049958002670Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Reusable, RF2023-06-29
04049958002687Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron Holmium Laser Fiber Cable, Reusable, RF2023-06-29
04049958002694Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron Holmium Laser Fiber Cable, Reusable, RF2023-06-29
04049958002700Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 micron Holmium Laser Fiber Cable, Reusable, R2023-06-29
04049958002717Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958002724Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
04049958002731Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Reusable, RF2023-06-29
04049958003783Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Reusable, Fr2023-06-29
04049958003806Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 micron Holmium Laser Fiber Cable, Reusable, Fr2023-06-29
04049958003813Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 micron Holmium Laser Fiber Cable, Reusable, Fr2023-06-29
04049958003820Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 micron Holmium Laser Fiber Cable, Reusable, F2023-06-29
04049958003905Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 micron Holmium Laser Fiber Cable, Single Use, 2023-06-29
00810116022618Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA UroBeam Diode Laser 2023-06-28
00810116022656Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA Diode Laser Fiber wi2023-06-28
00810116022670Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA Diode Laser Fiber wi2023-06-28
00810116022694Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use SMA Diode Laser Fiber wi2023-06-28
00810116022755Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 400 µm Single-Use ND YAG Laser Fiber 3.5m2023-06-28
00810116022779Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier 600 µm Single-Use ND YAG Laser Fiber 3.5m2023-06-28
10810116023063Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier SingleFlex 200 High Energy Ball Tip Laser 2023-06-28
10810116023148Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 200 High Energy Reusable (5X)2023-06-28
10810116023155Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 270 High Energy Reusable (5X)2023-06-28
10810116023162Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 400 High Energy Reusable (5X)2023-06-28
10810116023179Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 600 High Energy Reusable (5X)2023-06-28
10810116023186Dornier MedTechDORNIER MEDTECH AMERICA, INC.DMTL SmartFlex 1000 High Energy Reusable (5X)2023-06-28
10810116023261Dornier MedTechDORNIER MEDTECH AMERICA, INC.200 Micron SU Thulio High Performance 3m Fiber2023-06-28
10810116023278Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron SU Thulio Slim Performance 3m Fiber2023-06-28
10810116023285Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron SU Thulio Performance 3m Fiber2023-06-28
10810116023292Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron SU Thulio Performance 3m Fiber2023-06-28
10810116023308Dornier MedTechDORNIER MEDTECH AMERICA, INC.400 Micron SU Thulio Performance 4.5m Fiber2023-06-28
10810116023315Dornier MedTechDORNIER MEDTECH AMERICA, INC.600 Micron SU Thulio Performance 3m Fiber2023-06-28
10810116023322Dornier MedTechDORNIER MEDTECH AMERICA, INC.1000 Micron SU Thulio Performance 3m Fiber2023-06-28
10810116023339Dornier MedTechDORNIER MEDTECH AMERICA, INC.200 Micron SU Thulio Performance Ball-Tip 3m Fiber2023-06-28
10810116023346Dornier MedTechDORNIER MEDTECH AMERICA, INC.270 Micron SU Thulio Performance Ball-Tip 3m Fiber2023-06-28
10810116023445Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 200µM 3M PERF. FIBER 3ST 10X USE2023-06-28
10810116023469Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 270µM 3M SLIM PERF. 3ST 10X USE2023-06-28
10810116023476Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 400µM 3M PERF. FIBER 3ST 10X USE2023-06-28
10810116023483Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 600µM 3M PERF. FIBER 3ST 10X USE2023-06-28
10810116023490Dornier MedTechDORNIER MEDTECH AMERICA, INC.THULIO LL-R TM 1000µM 3M PERF. FIBER 3ST 10X USE2023-06-28
00810116020522Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier Medilas H 270 Micron Single Use Laser Fibe2023-06-27
00810116020539Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier Medilas H 400 Micron Single Use Laser Fibe2023-06-27
00810116020546Dornier MedTechDORNIER MEDTECH AMERICA, INC.Dornier Medilas H 270 Micron Single Use Ball Tip L2023-06-27
10810116023506Dornier MedTechDORNIER MEDTECH AMERICA, INC.Holmium 400um 3M Fiber 3ST 10X Use - LATAM Non-RFI2023-06-27
10810116023452Dornier MedTechDORNIER MEDTECH AMERICA, INC.Holmium 270um 3M Fiber 3ST 10X Use- LATAM Non-RFID2023-06-26
B0505LF0101X5503FibernexTYPENEX MEDICAL LLCLF0101X5502016-12-27
B050LF0101X2003FibernexTYPENEX MEDICAL LLCLF0101X2002016-12-22
B050LF0101X2723FibernexTYPENEX MEDICAL LLCLF0101X2722016-12-22
B050LF0101X3653FibernexTYPENEX MEDICAL LLCLF0101X3652016-12-27
B050LF0101X9403FibernexTYPENEX MEDICAL LLCLF0101X9402016-12-27
B050LF0201X2003FibernexTYPENEX MEDICAL LLCLF0201X2002016-12-27
B050LF0201X2723FibernexTYPENEX MEDICAL LLCLF0201X2722016-12-27
B050LF0201X3653FibernexTYPENEX MEDICAL LLCLF0201X3652016-12-27
B050LF0201X5503FibernexTYPENEX MEDICAL LLCLF0201X5502016-12-27
B050LF0201X9403FibernexTYPENEX MEDICAL LLCLF0201X9402016-12-27
B050MF200RST2051Typenex Surgical Reusable Optical Fiber TYPENEX MEDICAL LLCMF200RST2052016-09-06
B050MF200ST2051Typenex Surgical Single Use Optical FiberTYPENEX MEDICAL LLCMF200ST2052016-08-25
B050MF272RST2051Typenex Surgical Reusable Optical Fiber TYPENEX MEDICAL LLCMF272RST2052016-09-06
B050MF272ST2051Typenex Surgical Single Use Optical FiberTYPENEX MEDICAL LLCMF272ST2052016-08-26
B050MF365RST2051Typenex Surgical Reusable Optical Fiber TYPENEX MEDICAL LLCMF365RST2052016-09-06
B050MF365ST2051Typenex Surgical Single Use Optical Fiber TYPENEX MEDICAL LLCMF365ST2052016-08-26
B050MF550RST2051Typenex Surgical Reusable Optical Fiber TYPENEX MEDICAL LLCMF550RST2052016-09-06
B050MF550ST2051Typenex Surgical Single Use Optical FiberTYPENEX MEDICAL LLCMF550ST2052016-08-26
B050MF800RST2051Typenex Surgical Reusable Optical Fiber TYPENEX MEDICAL LLCMF800RST2052016-09-06
B050MF800ST2051Typenex Surgical Single Use Optical Fiber TYPENEX MEDICAL LLCMF800ST2052016-08-26
04049958002618Dornier MedTechDornier MedTech Laser GmbHMedilas H30 Laser2018-09-13
04049958002625Dornier MedTechDornier MedTech Laser GmbHMedilas HRM Laser2018-09-13
04049958002854Dornier MedTechDornier MedTech Laser GmbHMedilas H30 Laser2018-09-13
04049958002861Dornier MedTechDornier MedTech Laser GmbHMedilas HRM Laser2018-09-13
04049958003707Dornier MedTechDornier MedTech Laser GmbHMedilas H30 Laser2018-09-13
04049958004025Dornier MedTechDornier MedTech Laser GmbHMedilas H35 Laser2018-09-13
04049958004032Dornier MedTechDornier MedTech Laser GmbHMedilas H35 Laser2018-09-13
04055207053980MEGAPULSE 15+Richard Wolf GmbH4875012352017-06-28
04055207054000MEGAPULSE 15+Richard Wolf GmbH4875013652017-06-28