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FDA 510(k)

Medical Laser System Incanto / Evoline Platinum /Evoline

K号: K243630 · 2025-03-21

申请人Solar LS Cjsc
决定日期2025-03-21
产品代码GEX
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Medical Laser System Incanto / Evoline Platinum /Evoline is the device name listed in this FDA 510(k) record. The listed applicant is Solar LS Cjsc. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K243630. 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 Laser System Incanto / Evoline Platinum /Evoline?

Medical Laser System Incanto / Evoline Platinum /Evoline is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Solar LS Cjsc. The 510(k) number is K243630.

When did Medical Laser System Incanto / Evoline Platinum /Evoline receive FDA 510(k) clearance?

Medical Laser System Incanto / Evoline Platinum /Evoline received FDA 510(k) clearance on 2025-03-21, under 510(k) number K243630.

Who is the listed applicant for Medical Laser System Incanto / Evoline Platinum /Evoline?

The FDA 510(k) record lists Solar LS Cjsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Laser System Incanto / Evoline Platinum /Evoline?

The FDA product code for Medical Laser System Incanto / Evoline Platinum /Evoline 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。

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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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