LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253951

    Validate with FDA (Live)

    Device Name
    Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
    Manufacturer
    Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
    Date Cleared
    2026-03-06

    (86 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K201455
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Holmium Laser Therapeutic Apparatus are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology,Urinary Lithotripsy, Gastroenterology,ENT, Gynecology and general surgery.

    Device Description

    The HZ Series is a family of pulsed solid-state Holmium:YAG laser systems that deliver energy at a wavelength of 2100 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a diode-pumped Ho:YAG laser medium, and the laser energy is transmitted to the target site via SMA-905 compatible optical fibers. All models in the series share the same fundamental design and operational principles, differing in maximum average power output, Energy per pulse and frequency. The system includes a touchscreen interface, single-pedal footswitch, integrated liquid cooling, and multiple built-in safety features such as a key switch, emergency stop and door interlock, and real-time monitoring of laser output.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1