FDA 510(k)

메디칼렉산드라이트와 Nd:YAG 레이저 테라피 시스템 (CM11LP)

K-번호: K253828 · 2026-02-27

신청자Beijing HuaCheng Taike Technology Co., Ltd.

결정일2026-02-27

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Beijing HuaCheng Taike Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K253829의료 울트라-파이코 레이저 치료 시스템 (CM-SP-1064&532)K210663피부과 디오드 레이저 시스템

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