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510(k) K232789

VIO System (V-1000) by Enspectra Health, Inc. — Product Code QZN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 22, 2023
Date Received: September 11, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Multi-Photon Imaging
Device Class: Class II
Regulation Number: 878.4580
Review Panel: SU
Submission Type

To provide visible illumination of the surgical field or the patient