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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Laser With Mr Thermography
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
Scheelevägen 2
Lund,  SE 22381
Applicant Contact Dan Mogren
Correspondent
Omedtech, LLC
P.O. Box 1345
Frisco,  TX  75034
Correspondent Contact David Makanani
Regulation Number878.4810
Classification Product Code
ONO  
Date Received04/28/2025
Decision Date 09/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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