Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)

The Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System are laser surgical instruments that deliver pulsed near-infrared light (1940nm wavelength) through delivery fibers for soft tissue incision, excision, resection, ablation, coagulation, and hemostasis. The Elyra™ Plus additionally enables vaporization and has indications for benign prostatic hyperplasia treatment. Both are intended for use in urology, lithotripsy, and related endoscopic procedures.

The subject device operates at 1920–1960 nm wavelength with pulsed wave emission, frequencies of 1–2220 Hz, pulse durations of 50 μs–60 ms, and peak power up to 500 W. It includes single-use and reusable fibers with core diameters from 150 to 940 µm in flat and ball tip configurations, each with RFID tags. Minor differences from the predicate include additional fiber sizes (272 µm single-use ball tip), slightly lower frequency range, shorter pulse durations, and a dual-color aiming beam (green and blue options).

IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-1-6:2010, IEC 60601-2-22:2019, IEC 60825-1:2014, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-23. Performance testing included physical/mechanical verification, system reliability, software verification, laser control accuracy, electromagnetic compatibility, electrical and thermal safety, cybersecurity, packaging integrity, and human factors validation.

The subject device is substantially equivalent to the SOLTIVE™ Laser System (K183647) predicate because both are thulium fiber lasers with the same wavelength, emission mode, pulse energy, average power, peak power, and operating conditions used for identical urological and lithotripsy indications. Minor parameter differences (fiber sizes, frequency, pulse duration, aiming beam color) were evaluated through performance testing and determined not to alter safety and effectiveness; no clinical testing was required.