510(k) K251298 ยท ONO Neurosurgical Laser With Mr Thermography
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 |
| Decision | Substantially Equivalent, Sep 4, 2025 |
| Received | Apr 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251298
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.