FDA Product Code
FDA Product Code ONO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262315 | NeuroBlate System | Monteris Medical | 2026-09-03 | Traditional | PDF ↗ |
| K260976 | NeuroBlate System | Monteris Medical | 2026-04-23 | Special | PDF ↗ |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Medtronic Navigation, Inc. | 2026-03-13 | Traditional | PDF ↗ |
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) | Clinical Laserthermia Systems, AB | 2025-09-04 | Traditional | PDF ↗ |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation | 2025-05-29 | Traditional | PDF ↗ |
| K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024-06-04 | Traditional | PDF ↗ |
| K214125 | TRANBERG Thermoguide Therapy System | Clinical Laserthermia Systems, AB | 2022-09-22 | Traditional | PDF ↗ |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | 2022-01-07 | Traditional | PDF ↗ |
Product code ONO · Class II · General, Plastic Surgery. Data: openFDA.