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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 K253391
Device Name Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
Applicant
Medtronic Navigation, Inc.
200 Medtronic Dr.
Lafayette,  CO  80026
Applicant Contact Sharon McDermott
Correspondent
Medtronic Navigation, Inc.
200 Medtronic Dr.
Lafayette,  CO  80026
Correspondent Contact Sharon McDermott
Regulation Number878.4810
Classification Product Code
ONO  
Subsequent Product Code
GEX  
Date Received09/30/2025
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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