Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
FDA 510(k) K251298 · Clinical Laserthermia Systems, AB
510(k) numberK251298
Submission
- Device name
- Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
- Applicant
- Clinical Laserthermia Systems, AB
Lund, SE - Received
- April 28, 2025
- Decision date
- September 4, 2025
- 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 |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…ONO · Traditional | Medtronic Navigation, Inc. | 03/13/2026SE |
| 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 |
|---|---|---|
| K214125 | TRANBERG Thermoguide Therapy SystemONO · Traditional | 09/22/2022SE |
| K201466 | Tranberg CLS Laser ApplicatorGEX · Traditional | 03/26/2021SE |
| K163103 | Tranberg CLS Diffusor Laser FiberGEX · Special | 03/23/2017SE |
| K151569 | Tranberg CLS Laser FiberGEX · Traditional | 02/12/2016SE |
| K142216 | Tranberg CLS Thermal Therapy SystemGEX · Traditional | 04/21/2015SE |
Questions and answers
When was Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) cleared by the FDA?
Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) (K251298) received a 510(k) decision of Substantially Equivalent on September 4, 2025, 129 days after the submission was received.
What is the product code of K251298?
The FDA product code is ONO – Neurosurgical Laser With Mr Thermography, a Class II (moderate risk) device regulated under 21 CFR 878.4810.