FDA 510(k)

医疗二极管激光系统（THEIA808）

K号: K250018 · 2025-04-01

决定日期2025-04-01

产品代码GEX

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决定实质等同

器械摘要

Medical Diode Laser Systems (THEIA808) is the device name listed in this FDA 510(k) record. The listed applicant is Gigaalaser Company , Ltd.. It received FDA 510(k) clearance on 2025-04-01 under 510(k) number K250018. 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 Medical Diode Laser Systems (THEIA808)?

Medical Diode Laser Systems (THEIA808) is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is Gigaalaser Company , Ltd.. The 510(k) number is K250018.

When did Medical Diode Laser Systems (THEIA808) receive FDA 510(k) clearance?

Medical Diode Laser Systems (THEIA808) received FDA 510(k) clearance on 2025-04-01, under 510(k) number K250018.

Who is the listed applicant for Medical Diode Laser Systems (THEIA808)?

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

What is the FDA product code for Medical Diode Laser Systems (THEIA808)?

The FDA product code for Medical Diode Laser Systems (THEIA808) is GEX. This falls under the Gastroenterology category.

列明Gigaalaser Company , 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。

K242755医疗二极管激光系统（VELAS II-30B，VELAS II-30A，GBOX-15AB，GBOX-20B，CHEESE II-10B）K241791医疗二极管激光系统（GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D）K230047医疗二极管激光系统

官方来源

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