Panels › General, Plastic Surgery › Product code ONO · Class 2
Neurosurgical Laser With Mr Thermography
Regulation 878.4810
3510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in ONO
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Navigation | 3 | 1 |
| Monteris Medical | 3 | 0 |
| Clinical Laserthermia Systems, AB | 2 | 0 |
| 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 | K053087 K181859 +1 |
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