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FDA 510(k)

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

K-Number: K253828 · 2026-02-27

ApplicantBeijing HuaCheng Taike Technology Co., Ltd.
Decision Date2026-02-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) is a medical device manufactured by Beijing HuaCheng Taike Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-27 under approval 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.

Frequently Asked Questions

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. It is manufactured by Beijing HuaCheng Taike Technology Co., Ltd.. The 510(k) number is K253828.

When was Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) approved by the FDA?

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

What company makes Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)?

Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) is manufactured by Beijing HuaCheng Taike Technology Co., Ltd..

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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Related PubMed Literature

PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Beijing HuaCheng Taike Technology Co., Ltd.

K210663Dermatological Diode Laser Systems K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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