FDA 510(k)

鐵鐵激光治療儀器（HZ-40）

K 號：K253633 · 2026-01-24

申請人Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

決定日期2026-01-24

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.