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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 a medical device manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. It received FDA 510(k) clearance on 2026-01-24 under approval 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. It is manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K253633.

When was Holmium Laser Therapeutic Apparatus (HZ-40) approved by the FDA?

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

What company makes Holmium Laser Therapeutic Apparatus (HZ-40)?

Holmium Laser Therapeutic Apparatus (HZ-40) is manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd..

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 Devices by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

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) K242888Electrohydraulic Lithotriptor (TCS-B3-II) K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)

View all 7 devices →

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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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