Rhein Laser Technologies Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Medical Thulium Fiber Laser System (UroFiber 60Q) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Medical Thulium Fiber Laser System (UroFiber 60Q) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Medical Thulium Fiber Laser System (UroFiber 60Q) consists of a host (including a power supply, thulium fiber laser, safety control module, cooling module), foot switch and optical fiber (disposable use, sterilized by the user before use. Model: RL-150, RL-200, RL-272, RL-365, RL-550, RL-800, RL-1000).
Summary parsed at:2026-06-01 05:29:19 UTC
No later 510(k)s cite this device yet
Other submissions will appear here when they list K242293 as a predicate
