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FDA 510(k)

雷射纖維（PT-OF-A-S）；雷射纖維（PT-OF-B-S）；雷射纖維（PT-OF-C-S）；雷射纖維（PT-OF-D-S）；雷射纖維（PT-OF-E-S）；雷射纖維（PT-OF-F-S）

K 號：K253007 · 2025-11-20

申請人Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
決定日期2025-11-20
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

Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) 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 2025-11-20 under 510(k) number K253007. 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 Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)?

Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K253007.

When did Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) receive FDA 510(k) clearance?

Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) received FDA 510(k) clearance on 2025-11-20, under 510(k) number K253007.

Who is the listed applicant for Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)?

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 Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)?

The FDA product code for Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) is GEX. This falls under the Gastroenterology category.

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官方來源

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