Holmium Laser Therapeutic Apparatus (HZ-40)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253633

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

Identifiers

510(k) Number: K253633 FDA 510(k)
FDA Product Code: GEX FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4810 FDA 510(k)
Regulation Number: 878.4810 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Holmium Laser Therapeutic Apparatus (HZ-40) is a laser surgical instrument designed for therapeutic procedures, employing holmium laser technology to deliver precise energy to target tissues. It is intended for use in surgical settings where controlled laser ablation or fragmentation is required.

The device was cleared through the FDA 510(k) pathway (K253633) on January 24, 2026, with a traditional clearance type and a decision of substantially equivalent. It is marketed by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., identified by product code GEX, and is supplied as a complete apparatus. Regulatory documentation lists the device as a Holmium Laser Therapeutic Apparatus (HZ-40) without additional claims regarding sterility, single‑use status, or MRI safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Holmium Laser HZ Series - Potent Medical, Holmium Laser Therapeutic Apparatus (HZ-40) (K253633) — FDA 510(k ..., 2026 HZ Seires 40W Laser - GUANGZHOU POTENT MEDICAL EQUIPMENT JOINT ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K253633	Class II	Active

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Manufacturer

Manufacturer: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Sources (1)

FDA 510(k) K253633 24 fields · synced Oct 6, 2026