FDA 510(k)

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)

Numéro K : K261817 · 2026-09-17

DemandeurZhengzhou PZ Laser Slim Technology Co., Ltd.

Date de décision2026-09-17

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) 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 2026-09-17 under 510(k) number K261817. 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 Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)?

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K261817.

When did Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) receive FDA 510(k) clearance?

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) received FDA 510(k) clearance on 2026-09-17, under 510(k) number K261817.

Who is the listed applicant for Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)?

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 Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)?

The FDA product code for Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) is GEX. This falls under the Gastroenterology category.

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Source officielle

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