510(k) K211517 ยท GEX Powered Laser Surgical Instrument
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
| Applicant | Convergent Laser Technologies, Alameda CA, US |
| Decision | Substantially Equivalent, Nov 9, 2021 |
| Received | May 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211517
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.