FDA 510(k)

Medical Picosecond ND: YAG Laser System (PZ-6)

Número K: K250041 · 2025-05-14

RequerenteZhengzhou PZ Laser Slim Technology Co., Ltd.

Data da decisão2025-05-14

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Picosecond ND: YAG Laser System (PZ-6) is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K250041. 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 Picosecond ND: YAG Laser System (PZ-6)?

Medical Picosecond ND: YAG Laser System (PZ-6) is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K250041.

When did Medical Picosecond ND: YAG Laser System (PZ-6) receive FDA 510(k) clearance?

Medical Picosecond ND: YAG Laser System (PZ-6) received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250041.

Who is the listed applicant for Medical Picosecond ND: YAG Laser System (PZ-6)?

The FDA 510(k) record lists Zhengzhou PZ Laser Slim Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Picosecond ND: YAG Laser System (PZ-6)?

The FDA product code for Medical Picosecond ND: YAG Laser System (PZ-6) is GEX. This falls under the Gastroenterology category.

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Outros registros que listam Zhengzhou PZ Laser Slim Technology Co., Ltd. como candidato(a)

K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)K252732Sistema de Laser de Tiumínio-1927nm (PZ-DJG75-01, PZ-DJG75-02)K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)

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Fonte oficial

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