FDA 510(k)

TRI-BEAM PRO, TRI-BEAM (Nd:YAG 激光单元)

K号: K251464 · 2025-10-03

决定日期2025-10-03

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

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K251464. 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 TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Jeisys Medical Incorporated. The 510(k) number is K251464.

When did TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) receive FDA 510(k) clearance?

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K251464.

Who is the listed applicant for TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

FDA 510(k)记录显示Jeisys Medical Incorporated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 TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

The FDA product code for TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) is GEX. This falls under the Gastroenterology category.

列明Jeisys Medical Incorporated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。

K254185Potenza Prime K250065DENSITY; DENZA; DENSITY 黑色 K192545Potenza

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。