FDA 510(k)

钬光纤激光系统（TFL-A）；钬光纤激光系统（TFL-B）

K号: K252787 · 2025-11-24

申请人Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

决定日期2025-11-24

产品代码GEX

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决定实质等同

器械摘要

Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K252787. 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 Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)?

Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K252787.

When did Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) receive FDA 510(k) clearance?

Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) received FDA 510(k) clearance on 2025-11-24, under 510(k) number K252787.

Who is the listed applicant for Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)?

The FDA 510(k) record lists Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)?

The FDA product code for Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) is GEX. This falls under the Gastroenterology category.

列明Guangzhou Potent Medical Equipment Joint-Stock Co., 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。

K253951Holmium 激光治疗装置 (HZ-A)；Holmium 激光治疗装置 (HZ-B)；Holmium 激光治疗装置 (HZ-E)K253633Holmium 激光治疗装置 (HZ-40)K252771Holmium 激光系统 (Potent HP90)；Holmium 激光系统 (Potent HP100)；Holmium 激光系统 (Potent HP9120)；Holmium 激光系统 (Potent HP140)；Holmium 激光系统 (Potent HP150)K253007激光光纤（PT-OF-A-S）；激光光纤（PT-OF-B-S）；激光光纤（PT-OF-C-S）；激光光纤（PT-OF-D-S）；激光光纤（PT-OF-E-S）；激光光纤（PT-OF-F-S）K243032EHL探头（SCDG-AS）；EHL探头（SCDG-BS）；EHL探头（SCDG-CS）K242888电液压碎石机（TCS-B3-II）

查看所有 7 个设备 →

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