FDA 510(k)

LASER THERMAL THERAPY KIT

K号: K260632 · 2026-03-17

决定日期2026-03-17

产品代码GEX

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决定实质等同

器械摘要

LASER THERMAL THERAPY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Elesta S.P.A. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K260632. 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 LASER THERMAL THERAPY KIT?

LASER THERMAL THERAPY KIT is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is Elesta S.P.A. The 510(k) number is K260632.

When did LASER THERMAL THERAPY KIT receive FDA 510(k) clearance?

LASER THERMAL THERAPY KIT received FDA 510(k) clearance on 2026-03-17, under 510(k) number K260632.

Who is the listed applicant for LASER THERMAL THERAPY KIT?

FDA 510(k)记录显示Elesta S.P.A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 LASER THERMAL THERAPY KIT?

The FDA product code for LASER THERMAL THERAPY KIT is GEX. This falls under the Gastroenterology category.

列明Elesta S.P.A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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