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FDA 510(k)

SMARTRION COMBI/Alexandrite & 长脉冲 Nd:YAG 激光

K号: K222485 · 2023-03-29

申请人Ids, Limited
决定日期2023-03-29
产品代码GEX
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决定实质等同

器械摘要

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is the device name listed in this FDA 510(k) record. The listed applicant is Ids, Limited. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K222485. 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 SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Ids, Limited. The 510(k) number is K222485.

When did SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser receive FDA 510(k) clearance?

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser received FDA 510(k) clearance on 2023-03-29, under 510(k) number K222485.

Who is the listed applicant for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

The FDA 510(k) record lists Ids, Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

The FDA product code for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is GEX. This falls under the Gastroenterology category.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：GEX）

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。

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官方来源

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