Dornier Thulio

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 calculi; b) Surgical procedures involving soft tissue ablation, vaporization, excision, incision, and coagulation.

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.

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 of 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 pedal. The 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. The fibers as noted below, are the same design as cleared in 510k's K984591, K121938, K152591 and K161771.