510(k) K253391 ยท ONO Neurosurgical Laser With Mr Thermography
Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
| Applicant | Medtronic Navigation, Inc., Lafayette CO, US |
| Decision | Substantially Equivalent, Mar 13, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253391
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.