Product code ONO— General, Plastic Surgery
NeuroBlate System
- Classification name
- Neurosurgical Laser With Mr Thermography
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 8
- First cleared
- Most recent
FDA classification definition
“Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.”
Market context for product code ONO
FDA has cleared devices under product code ONO between 2022 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2024
- 2022
Top applicants under product code ONO
Recent clearances under product code ONO
- K262315 — NeuroBlate System
- K260976 — NeuroBlate System
- K253391 — Visualase Cooled Laser Applicator System (3 models)
- K251298 — Mobile Laser Unit (1001-N2) +3 more
- K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422)
- K240877 — Monteris Medical NeuroBlate System
- K214125 — TRANBERG Thermoguide Therapy System
- K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4)
Data sourced from openFDA. This site is unofficial and independent of the FDA.