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510(k) Data Aggregation

    K Number
    K213252
    Device Name
    Dornier Thulio
    Manufacturer
    DornierMedTech America, Inc
    Date Cleared
    2022-07-27

    (300 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    DornierMedTech America, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier Thulio Laser is intended for minimally-invasive stone fragmentation, surgical tissue preparation such as cutting, ablation, coagulation and vaporization, in the following medical specialties: Urology a) Lithotripsy - Endoscopic fragmentation and pulverization of urethral, ureteral, bladder and renal stones - b) Benign Prostatic Hyperplasia (BPH) - c) Urethral Strictures - d) Bladder Neck Incision of the Prostate (BNI) e) Superficial and invasive bladder, urethral and ureteral tumors
    Device Description
    The Dornier Thulio is a compact, mobile, diode pumped Thulium, pulsed, single wavelength surgical laser with a wavelength of 2013 nm. The Dornier Thulio laser is comprised two functional components: (1) a laser console and (2) a dual pedal footswitch (wired or wireless). The laser console emits laser radiation which is transmitted to the application site by a sterile fiber optic delivery system (fiber cable) with a SMA 905 connector. A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the user. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser. Laser energy is transmitted by depressing a foot pedals, both the wired and wireless models, are water-proof and explosion-proof. The Dornier Thulio laser also has the same principles of operation as other currently available medical lasers (switch on the device, set energy, set frequency, set laser mode, connect the lightguide, prepare the footswitch, activate the laser device). The laser energy is transmitted via the use of a laser fiber connected to the Thulio laser.
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