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510(k) Data Aggregation

    K Number
    K252787
    Date Cleared
    2025-11-24

    (83 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Thulium Fiber Laser System is intended for incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft tissue, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

    Urology

    • Ablation of Benign Prostatic Hyperplasia (BPH)
    • Laser Resection of the Prostate (LRP)
    • Laser Enucleation of the Prostate (LEP)
    • Laser Ablation of the Prostate (LAP)
    • Transurethral Incision of the Prostate (TUIP)
    • Condylomas
    • Urethral strictures
    • Lesions of external genitalia
    • Bladder neck incisions (BNI)
    • Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
    • Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
    • Treatment of distal impacted fragments remaining in the ureters following lithotripsy

    Lithotripsy and Percutaneous Urinary Lithotripsy

    • Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate monohydrate and calcium oxalate dehydrate stones
    • Endoscopic fragmentation of renal calculi
    • Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

    Gastroenterology
    open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:

    • Appendectomy
    • Angiodysplasia
    • Polyps
    • Colorectal cancer
    • Biopsy
    • Telangiectasias
    • Gall Bladder calculi
    • Telangiectasias of the osler-weber-Renu disease
    • Biliary/Bile duct calculi vascular Malformation
    • Ulcers
    • Gastritis
    • Gastric ulcers
    • Esophagitis
    • Duodenal ulcers
    • Esophageal ulcers
    • Non Bleeding ulcers
    • Varices
    • Pancreatitis
    • Colitis
    • Haemorrhoids
    • Mallory-weiss tear
    • Cholecystectomy
    • Gastric Erosions
    • Benign and Malignant Neoplasm

    Gynecology
    Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

    Device Description

    The Thulium Fiber Laser System is a pulsed solid-state Thulium fiber laser system that delivers energy at a wavelength of 1940 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a diode-pumped Thulium-doped fiber laser medium, and the laser energy is transmitted to the target site via standard optical fibers. The system is designed for surgical applications requiring precise tissue ablation, coagulation, and stone fragmentation.

    The system includes an intuitive touchscreen interface, dual-pedal foot switch, integrated cooling system, and comprehensive safety features including emergency stop, door interlock, key switch, and real-time monitoring of laser parameters.

    AI/ML Overview

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