510(k) K232789
K232789 is an FDA 510(k) premarket notification submitted by Enspectra Health, Inc. for the device "VIO System (V-1000)". The FDA issued a decision of Substantially Equivalent on December 22, 2023. The device falls under product code QZN (Multi-Photon Imaging), a Class II device regulated under 21 CFR 878.4580.
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