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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 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 2025-10-23 under 510(k) 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. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K252732.

When did 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) receive FDA 510(k) clearance?

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

Who is the listed applicant for 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)?

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-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.

Other records listing Zhengzhou PZ Laser Slim Technology Co., Ltd. as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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