K181859 is an FDA 510(k) clearance for the Visualase Thermal Therapy System. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on March 6, 2019, 237 days after receiving the submission on July 12, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K181859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2018 |
| Decision Date | March 06, 2019 |
| Days to Decision | 237 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |