The following data is part of a premarket notification filed by Medtronic Navigation Inc. with the FDA for Visualase Thermal Therapy System.
| Device ID | K181859 |
| 510k Number | K181859 |
| Device Name: | Visualase Thermal Therapy System |
| Classification | System, Image Processing, Radiological |
| Applicant | Medtronic Navigation Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Rishi Sinha |
| Correspondent | Sharon L. Mcdermott Medtronic Navigation Inc. 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | LLZ |
| Subsequent Product Code | FRN |
| Subsequent Product Code | GEX |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2019-03-06 |