LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252771
    Device Name
    Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
    Manufacturer
    Guangzhou Potent Medical Equipment Joint-Stock Co. , Ltd.
    Date Cleared
    2025-11-24

    (83 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K161257,K201455
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Holmium laser system 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, Arthroscopy, Discectomy, Gynecology, ENT and General Surgery.

    Device Description

    The Potent HP 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 flashlamp-pumped Ho:YAG laser medium, and the laser energy is transmitted to the target site via SMA905-compatible optical fibers. All models in the series share the same fundamental design and operational principles, differing in maximum average power output and frequency. The system includes a touchscreen interface, dual-pedal footswitch, fiber auto-recognition, integrated liquid cooling, and multiple built-in safety features such as an emergency stop, 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