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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 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 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. The listed applicant is Beijing HuaCheng Taike Technology Co., Ltd.. The 510(k) number is K253829.

When did Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) receive FDA 510(k) clearance?

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

Who is the listed applicant for Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)?

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 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.

Other records listing Beijing HuaCheng Taike Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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