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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diagnostic Neurosurgical Microscope Filter
510(k) Number K254030
Device Name cCeLL405
Applicant
VPIX Medical, Inc.
774, Gyeryong-Ro, Jung-Gu
Daejeon,  KR 34873
Applicant Contact Kyungmin Hwang
Correspondent
VPIX Medical, Inc.
774, Gyeryong-Ro, Jung-Gu
Daejeon,  KR 34873
Correspondent Contact Kyungmin Hwang
Regulation Number882.4950
Classification Product Code
QFX  
Date Received12/16/2025
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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