FDA 510(k)

醫用亞歷山大石及Nd:YAG雷射治療系統（CM11LP）

K 號：K253828 · 2026-02-27

申請人Beijing HuaCheng Taike Technology Co., Ltd.

決定日期2026-02-27

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

Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing HuaCheng Taike Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-27 under 510(k) number K253828. 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 Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)?

Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) is a medical device that received FDA 510(k) clearance on 2026-02-27. The listed applicant is Beijing HuaCheng Taike Technology Co., Ltd.. The 510(k) number is K253828.

When did Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) receive FDA 510(k) clearance?

Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) received FDA 510(k) clearance on 2026-02-27, under 510(k) number K253828.

Who is the listed applicant for Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)?

The FDA 510(k) record lists Beijing HuaCheng Taike Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)?

The FDA product code for Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) is GEX. This falls under the Gastroenterology category.

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官方來源

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