FDA 510(k)

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

Número K: K253829 · 2026-02-27

RequerenteBeijing HuaCheng Taike Technology Co., Ltd.

Data da decisão2026-02-27

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Beijing HuaCheng Taike Technology Co., Ltd. como candidato(a)

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

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Fonte oficial

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