FDA 510(k)

Holmium Laser Therapeutic Apparatus (HZ-40)

K-Number: K253633 · 2026-01-24

ApplicantGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Decision Date2026-01-24

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Holmium Laser Therapeutic Apparatus (HZ-40) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. It received FDA 510(k) clearance on 2026-01-24 under 510(k) number K253633. 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 Holmium Laser Therapeutic Apparatus (HZ-40)?

Holmium Laser Therapeutic Apparatus (HZ-40) is a medical device that received FDA 510(k) clearance on 2026-01-24. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K253633.

When did Holmium Laser Therapeutic Apparatus (HZ-40) receive FDA 510(k) clearance?

Holmium Laser Therapeutic Apparatus (HZ-40) received FDA 510(k) clearance on 2026-01-24, under 510(k) number K253633.

Who is the listed applicant for Holmium Laser Therapeutic Apparatus (HZ-40)?

The FDA 510(k) record lists Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Holmium Laser Therapeutic Apparatus (HZ-40)?

The FDA product code for Holmium Laser Therapeutic Apparatus (HZ-40) is GEX. This falls under the Gastroenterology category.

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Other records listing Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. as applicant

K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)K242888Electrohydraulic Lithotriptor (TCS-B3-II)

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Related Devices (Code: GEX)

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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.