FDA 510(k)

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

N.º K: K261589 · 2026-09-02

SolicitanteZhengzhou PZ Laser Slim Technology Co., Ltd.

Fecha de decisión2026-09-02

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Zhengzhou PZ Laser Slim Technology Co., Ltd. como solicitante

K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)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 Tio Aluminio a 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)K250782Fractional CO2 Laser Machine

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.