Total clearances
7
2020-01-03 → 2026-09-03
Name variants in FDA filings: Monteris Medical, Inc. / Monteris Medical, / Monteris Medical
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| GEX |
Powered Laser Surgical Instrument |
Class II |
General, Plastic Surgery |
4 |
2023-12-08 |
| ONO |
Neurosurgical Laser With Mr Thermography |
Class II |
General, Plastic Surgery |
3 |
2026-09-03 |
Filings
All 510(k) clearances (7)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-09-03 |
K262315 |
NeuroBlate System |
ONO |
Class II |
General, Plastic Surgery |
| 2026-04-23 |
K260976 |
NeuroBlate System |
ONO |
Class II |
General, Plastic Surgery |
| 2024-06-04 |
K240877 |
Monteris Medical NeuroBlate System |
ONO |
Class II |
General, Plastic Surgery |
| 2023-12-08 |
K231061 |
NeuroBlate System |
GEX |
Class II |
General, Plastic Surgery |
| 2023-03-15 |
K222983 |
NeuroBlate Fusion-S Software V3.17 |
GEX |
Class II |
General, Plastic Surgery |
| 2020-08-21 |
K201056 |
NeuroBlate System |
GEX |
Class II |
General, Plastic Surgery |
| 2020-01-03 |
K193375 |
NeuroBlate System |
GEX |
Class II |
General, Plastic Surgery |