Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
FDA 510(k) K253391 · Medtronic Navigation, Inc.
510(k) numberK253391
Submission
- Device name
- Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
- Applicant
- Medtronic Navigation, Inc.
Lafayette, CO, US - Received
- September 30, 2025
- Decision date
- March 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONO – Neurosurgical Laser With Mr Thermography
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code ONO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262315 | NeuroBlate SystemONO · Traditional | Monteris Medical | 09/03/2026SE |
| K260976 | NeuroBlate SystemONO · Special | Monteris Medical | 04/23/2026SE |
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…ONO · Traditional | Clinical Laserthermia Systems, AB | 09/04/2025SE |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422)ONO · Traditional | Medtronic Navigation | 05/29/2025SE |
| K240877 | Monteris Medical NeuroBlate SystemONO · Traditional | Monteris Medical, | 06/04/2024SE |
| K214125 | TRANBERG Thermoguide Therapy SystemONO · Traditional | Clinical Laserthermia Systems, AB | 09/22/2022SE |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4)ONO · Traditional | Medtronic Navigation, Inc. | 01/07/2022SE |
More from Medtronic Navigation, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | 03/26/2026SE |
| K253395 | Stealth AXiS ENT clinical applicationPGW · Traditional | 03/16/2026SE |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical applicationOLO · Traditional | 02/12/2026SE |
| K251282 | StealthStation S8 Spine SoftwareOLO · Traditional | 10/17/2025SE |
| K242464 | Stealth Spine Clamps; ModuLeX Shank MountsOLO · Traditional | 06/05/2025SE |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422)ONO · Traditional | 05/29/2025SE |
| K240465 | O-arm O2 Imaging SystemOWB · Traditional | 06/21/2024SE |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585)HAW · Traditional | 10/19/2023SE |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4HAW · Traditional | 06/10/2022SE |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4)ONO · Traditional | 01/07/2022SE |
Questions and answers
When was Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) cleared by the FDA?
Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) (K253391) received a 510(k) decision of Substantially Equivalent on March 13, 2026, 164 days after the submission was received.
What is the product code of K253391?
The FDA product code is ONO – Neurosurgical Laser With Mr Thermography, a Class II (moderate risk) device regulated under 21 CFR 878.4810.