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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K251852
Device Name cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
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 Number876.1500
Classification Product Code
OWN  
Subsequent Product Code
GCJ  
Date Received06/17/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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