FDA 510(k)

Q-Switched Nd: YAG Laser machine (LFS-C13U)

K 號：K252319 · 2025-10-20

決定日期2025-10-20

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

Q-Switched Nd: YAG Laser machine (LFS-C13U) is the device name listed in this FDA 510(k) record. The listed applicant is Sanhe Lefis Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-10-20 under 510(k) number K252319. 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 Q-Switched Nd: YAG Laser machine (LFS-C13U)?

Q-Switched Nd: YAG Laser machine (LFS-C13U) is a medical device that received FDA 510(k) clearance on 2025-10-20. The listed applicant is Sanhe Lefis Electronics Co., Ltd.. The 510(k) number is K252319.

When did Q-Switched Nd: YAG Laser machine (LFS-C13U) receive FDA 510(k) clearance?

Q-Switched Nd: YAG Laser machine (LFS-C13U) received FDA 510(k) clearance on 2025-10-20, under 510(k) number K252319.

Who is the listed applicant for Q-Switched Nd: YAG Laser machine (LFS-C13U)?

The FDA 510(k) record lists Sanhe Lefis Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q-Switched Nd: YAG Laser machine (LFS-C13U)?

The FDA product code for Q-Switched Nd: YAG Laser machine (LFS-C13U) is GEX. This falls under the Gastroenterology category.

其他以 Sanhe Lefis Electronics Co., Ltd. 為申請人之記錄

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