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FDA 510(k)

Medical Thulium Fiber Laser Systems (UroFiber 60Q)

K-Number: K242293 · 2024-11-19

ApplicantRhein Laser Technologies Co., Ltd.
Decision Date2024-11-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Thulium Fiber Laser Systems (UroFiber 60Q) is a medical device manufactured by Rhein Laser Technologies Co., Ltd.. It received FDA 510(k) clearance on 2024-11-19 under approval number K242293. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Thulium Fiber Laser Systems (UroFiber 60Q)?

Medical Thulium Fiber Laser Systems (UroFiber 60Q) is a medical device that received FDA 510(k) clearance on 2024-11-19. It is manufactured by Rhein Laser Technologies Co., Ltd.. The 510(k) number is K242293.

When was Medical Thulium Fiber Laser Systems (UroFiber 60Q) approved by the FDA?

Medical Thulium Fiber Laser Systems (UroFiber 60Q) received FDA 510(k) clearance on 2024-11-19, under approval number K242293.

What company makes Medical Thulium Fiber Laser Systems (UroFiber 60Q)?

Medical Thulium Fiber Laser Systems (UroFiber 60Q) is manufactured by Rhein Laser Technologies Co., Ltd..

What is the FDA product code for Medical Thulium Fiber Laser Systems (UroFiber 60Q)?

The FDA product code for Medical Thulium Fiber Laser Systems (UroFiber 60Q) is GEX. This falls under the Gastroenterology category.

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Other Devices by Rhein Laser Technologies Co., Ltd.

K233757TitanPico Laser Workstation (PICO-450) K233756Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)

Related Devices (Code: GEX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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