FDA product code ONO: Neurosurgical Laser With Mr Thermography
ONO is the FDA product code for neurosurgical laser with mr thermography. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the Neurology panel. FDA has cleared 8 510(k) submissions under ONO, 8 in the last five years, from 5 different applicants. The average 510(k) review took 135 days (median 122); 91 days on average over the last three years. FDA has posted 1 recall for ONO devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Neurosurgical Laser With Mr Thermography |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | NE — Neurology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for ONO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 260 |
| 2024 | 1 | 67 |
| 2025 | 2 | 122 |
| 2026 | 3 | 84 |
Compare with all 510(k) review times · Search every ONO clearance
Top ONO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Monteris Medical | 2 | 2026-09-03 |
| Medtronic Navigation, Inc. | 2 | 2026-03-13 |
| Clinical Laserthermia Systems, AB | 2 | 2025-09-04 |
| Medtronic Navigation | 1 | 2025-05-29 |
| Monteris Medical, | 1 | 2024-06-04 |
Most recent ONO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262315 | Monteris Medical | NeuroBlate System | 2026-09-03 | 57 |
| K260976 | Monteris Medical | NeuroBlate System | 2026-04-23 | 30 |
| K253391 | Medtronic Navigation, Inc. | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | 2026-03-13 | 164 |
| K251298 | Clinical Laserthermia Systems, AB | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) | 2025-09-04 | 129 |
| K250307 | Medtronic Navigation | Visualase V2 MRI-guided Laser Ablation System (9736422) | 2025-05-29 | 115 |
Recalls for ONO devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-10-14.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code ONO?
ONO is the FDA product code for neurosurgical laser with mr thermography. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the Neurology panel.
What device class is ONO?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONO?
Across 8 cleared submissions the average was 135 days from receipt to decision (median 122).
Which companies have the most ONO clearances?
Monteris Medical (2); Medtronic Navigation, Inc. (2); Clinical Laserthermia Systems, AB (2); Medtronic Navigation (1); Monteris Medical, (1).
Have ONO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-10-14.
Next steps
- Run an FDA pathway report with predicate devices for product code ONO
- Run a recall and safety report across every ONO manufacturer
- Watch product code ONO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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