FDA 510(k)

1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)

Número K: K261821 · 2026-08-27

RequerenteZhengzhou PZ Laser Slim Technology Co., Ltd.

Data da decisão2026-08-27

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) 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 2026-08-27 under 510(k) number K261821. 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 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)?

1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) is a medical device that received FDA 510(k) clearance on 2026-08-27. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K261821.

When did 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) receive FDA 510(k) clearance?

1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) received FDA 510(k) clearance on 2026-08-27, under 510(k) number K261821.

Who is the listed applicant for 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)?

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 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)?

The FDA product code for 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) 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)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)K250782Fractional CO2 Laser Machine

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Fonte oficial

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