FDA 510(k)

Rapido 医疗激光器（Rapido MED，Rapido Derma，Rapido ENT，Rapido Podia）

K号: K240543 · 2024-10-24

决定日期2024-10-24

产品代码GEX

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决定实质等同

器械摘要

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is the device name listed in this FDA 510(k) record. The listed applicant is Medency S.R.L.. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K240543. 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 Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)?

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Medency S.R.L.. The 510(k) number is K240543.

When did Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) receive FDA 510(k) clearance?

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) received FDA 510(k) clearance on 2024-10-24, under 510(k) number K240543.

Who is the listed applicant for Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)?

The FDA 510(k) record lists Medency S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)?

The FDA product code for Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is GEX. This falls under the Gastroenterology category.

列明Medency S.R.L.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。

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