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FDA 510(k)

1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)

K-Number: K252732 · 2025-10-23

ApplicantZhengzhou PZ Laser Slim Technology Co., Ltd.
Decision Date2025-10-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) is a medical device manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-23 under approval number K252732. 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.

Frequently Asked Questions

What is the 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)?

1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) is a medical device that received FDA 510(k) clearance on 2025-10-23. It is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K252732.

When was 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) approved by the FDA?

1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) received FDA 510(k) clearance on 2025-10-23, under approval number K252732.

What company makes 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)?

1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) is manufactured by Zhengzhou PZ Laser Slim Technology Co., Ltd..

What is the FDA product code for 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)?

The FDA product code for 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Zhengzhou PZ Laser Slim Technology Co., Ltd.

K180353Diode laser hair removal device K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) K250782Fractional CO2 Laser Machine K250038Muscle Stimulator Device (PZ-100) K250041Medical Picosecond ND: YAG Laser System (PZ-6)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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