510(k) K252971 · GEX Powered Laser Surgical Instrument
Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Mar 17, 2026 |
| Received | Sep 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252971
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.