K251298

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)

510(k) number: K251298
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 SE
Product code: ONO — Neurosurgical Laser With Mr Thermography
Decision date: 2025-09-04
Date received: 2025-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

Also available from FDA: K251298.pdf

Official FDA record: K251298

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.