# K252971: Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 17, 2026 after 181 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K936109 (1994). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories), Olympus Surgical Technologies America (2019) Summary page 6.

## Indications for use
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 Prostrate (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

Source page: https://510kreport.com/device/K252971
Methodology: https://510kreport.com/methodology