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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 K262315
Device Name NeuroBlate System
Applicant
Monteris Medical
131 Cheshire Ln.
Suite 100
Minnetonka,  MN  55305
Applicant Contact Amber Daly
Correspondent
Monteris Medical
131 Cheshire Ln.
Suite 100
Minnetonka,  MN  55305
Correspondent Contact Amber Daly
Regulation Number878.4810
Classification Product Code
ONO  
Date Received07/08/2026
Decision Date 09/03/2026
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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