Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 150 mm laser probe with removable stylet and 1 temperature sensor, (1) 150 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in USA/EU/UK
A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a single-use device.
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