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

Elyra™ Thulium Fiber Laser System
The Elyra™ TFL System (Laser, Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation and hemostasis of soft tissue, with or without an endoscope, in the following indications: urology and lithotripsy.
Urology
• 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 dihydrate stones
• Endoscopic fragmentation of calculi
• Treatment of distal impacted fragments of steinstrasse when guidewire cannot be passed
Elyra™ Plus Thulium Fiber Laser System
The Elyra™ Plus TFL System (Laser, Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology and lithotripsy.
Urology
• Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [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 Indications
• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate monohydrate, and calcium oxalate dihydrate stones
• Endoscopic fragmentation of calculi
• Treatment of distal impacted fragments of steinstrasse when guidewire cannot be passed

The Elyra™ TFL System (Laser, Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation and hemostasis of soft tissue, with or without an endoscope, in the following indications: urology and lithotripsy. Urology: 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: Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate monohydrate, and calcium oxalate dihydrate stones, Treatment of distal impacted fragments of steinstrasse when guidewire cannot be passed.

The Elyra™ Thulium Fiber Laser (TFL) System (Elyra™ Plus, Elyra™, Elyra™ Thulium Laser Fibers and Accessories) is a thulium fiber laser which delivers a pulsed beam of near-infrared light (1940nm) through the active media of a single use or reusable delivery fiber. The system is contained in a mobile format and has an articulating graphical user interface display and built-in laser generator with the ability to connect to standard mains power. The Elyra™ TFL System is available in two models: the Elyra™ TFL System and the Elyra™ Plus TFL System. The lasers are similar devices with only the following differences: maximum average power output, frequency, pulse duration, pulse energy, maximum peak power, foot pedal options to activate energy delivery, vaporization and BPH indications. The Elyra™ TFL System and Elyra™ Plus TFL System includes a medical laser generator (which includes a blast shield, remote interlock connector, keys, and power cord), delivery fibers, and a footswitch (hybrid or wired). Safety goggles are provided with each system. The delivery fibers are available in standard tip and ball tip options as single use devices. Reusable fibers are only available in the standard tip option. Each fiber contains a unique radio frequency identification (RFID) tag that will allow the laser generator to identify certain aspects of the fiber, including UDI, catalog number, lot number, manufacture date, expiration date, size, max power and energy, and number of remaining uses (if applicable information once attached). Fibers are only compatible with Elyra™ systems.