FDA 510(k)

Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)

N.º K: K253828 · 2026-02-27

SolicitanteBeijing HuaCheng Taike Technology Co., Ltd.

Fecha de decisión2026-02-27

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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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Otros registros que enlistan a Beijing HuaCheng Taike Technology Co., Ltd. como solicitante

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Fuente oficial

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