FDA 510(k)

1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)

Número K: K261589 · 2026-09-02

RequerenteZhengzhou PZ Laser Slim Technology Co., Ltd.

Data da decisão2026-09-02

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) 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 2026-09-02 under 510(k) number K261589. 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 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)?

1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) is a medical device that received FDA 510(k) clearance on 2026-09-02. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K261589.

When did 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) receive FDA 510(k) clearance?

1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) received FDA 510(k) clearance on 2026-09-02, under 510(k) number K261589.

Who is the listed applicant for 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)?

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 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)?

The FDA product code for 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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