FDA 510(k)

二氧化碳激光治療系統（型號：LFS-D9U）

K 號：K250998 · 2025-12-19

決定日期2025-12-19

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

CO2 Laser Therapy System (Model: LFS-D9U) 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 2025-12-19 under 510(k) number K250998. 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 CO2 Laser Therapy System (Model: LFS-D9U)?

CO2 Laser Therapy System (Model: LFS-D9U) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Sanhe Lefis Electronics Co., Ltd.. The 510(k) number is K250998.

When did CO2 Laser Therapy System (Model: LFS-D9U) receive FDA 510(k) clearance?

CO2 Laser Therapy System (Model: LFS-D9U) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K250998.

Who is the listed applicant for CO2 Laser Therapy System (Model: LFS-D9U)?

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 CO2 Laser Therapy System (Model: LFS-D9U)?

The FDA product code for CO2 Laser Therapy System (Model: LFS-D9U) 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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官方來源

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