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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Photon Imaging
510(k) Number K232789
Device Name VIO System (V-1000)
Applicant
Enspectra Health, Inc.
2495 Hospital Dr., Suite 300
Mountain View,  CA  94040
Applicant Contact Grace Li
Correspondent
Enspectra Health, Inc.
2495 Hospital Dr., Suite 300
Mountain View,  CA  94040
Correspondent Contact Grace Li
Regulation Number878.4580
Classification Product Code
QZN  
Date Received09/11/2023
Decision Date 12/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT05619471
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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