510(k) K181859 ยท LLZ System, Image Processing, Radiological
Visualase Thermal Therapy System
| Applicant | Medtronic Navigation, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Mar 6, 2019 |
| Received | Jul 12, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2022 | Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE
FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures. Open, Classified |
ONO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.