FDA 510(k)

Holmium 激光治疗装置 (HZ-40)

K号: K253633 · 2026-01-24

申请人Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

决定日期2026-01-24

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253951Holmium 激光治疗装置 (HZ-A)；Holmium 激光治疗装置 (HZ-B)；Holmium 激光治疗装置 (HZ-E)K252787钬光纤激光系统（TFL-A）；钬光纤激光系统（TFL-B）K252771Holmium 激光系统 (Potent HP90)；Holmium 激光系统 (Potent HP100)；Holmium 激光系统 (Potent HP9120)；Holmium 激光系统 (Potent HP140)；Holmium 激光系统 (Potent HP150)K253007激光光纤（PT-OF-A-S）；激光光纤（PT-OF-B-S）；激光光纤（PT-OF-C-S）；激光光纤（PT-OF-D-S）；激光光纤（PT-OF-E-S）；激光光纤（PT-OF-F-S）K243032EHL探头（SCDG-AS）；EHL探头（SCDG-BS）；EHL探头（SCDG-CS）K242888电液压碎石机（TCS-B3-II）

查看所有 7 个设备 →

官方来源

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