FDA 510(k)

鐵鐵激光系統 (TFL-A)；鐵鐵激光系統 (TFL-B)

K 號：K252787 · 2025-11-24

申請人Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

決定日期2025-11-24

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.