FDA 510(k)

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

Numéro K : K261821 · 2026-08-27

DemandeurZhengzhou PZ Laser Slim Technology Co., Ltd.

Date de décision2026-08-27

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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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Source officielle

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