FDA 510(k)

泰坦皮科激光工作站（PICO-450）

K号: K233757 · 2024-04-11

决定日期2024-04-11

产品代码GEX

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决定实质等同

器械摘要

TitanPico Laser Workstation (PICO-450) is the device name listed in this FDA 510(k) record. The listed applicant is Rhein Laser Technologies Co., Ltd.. It received FDA 510(k) clearance on 2024-04-11 under 510(k) number K233757. 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.

常见问题

What is the TitanPico Laser Workstation (PICO-450)?

TitanPico Laser Workstation (PICO-450) is a medical device that received FDA 510(k) clearance on 2024-04-11. The listed applicant is Rhein Laser Technologies Co., Ltd.. The 510(k) number is K233757.

When did TitanPico Laser Workstation (PICO-450) receive FDA 510(k) clearance?

TitanPico Laser Workstation (PICO-450) received FDA 510(k) clearance on 2024-04-11, under 510(k) number K233757.

Who is the listed applicant for TitanPico Laser Workstation (PICO-450)?

FDA 510(k)记录将莱茵激光技术有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for TitanPico Laser Workstation (PICO-450)?

The FDA product code for TitanPico Laser Workstation (PICO-450) is GEX. This falls under the Gastroenterology category.

列明Rhein Laser Technologies Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261738医疗铥光纤激光系统（UroFiber 150Q）K242293医疗铥光纤激光系统（UroFiber 60Q）K233756Artemis 二极管激光系统 (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)

官方来源

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