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FDA 510(k)

Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)

K-Number: K253829 · 2026-02-27

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

Device Summary

Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) 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 K253829. 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 Ultra-Pico Laser Treatment System (CM-SP-1064&532)?

Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) 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 K253829.

When was Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) approved by the FDA?

Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) received FDA 510(k) clearance on 2026-02-27, under approval number K253829.

What company makes Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)?

Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) is manufactured by Beijing HuaCheng Taike Technology Co., Ltd..

What is the FDA product code for Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)?

The FDA product code for Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42096274 Nanoparticle-based approaches to tackling urinary tract biofilms. Nanomedicine (London, England) (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

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

K210663Dermatological Diode Laser Systems K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)

Related Devices (Code: GEX)

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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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