K232789
- 510(k) number
- K232789
- Device name
- VIO System (V-1000)
- Applicant
- Enspectra Health, Inc. CA · US
- Product code
- QZN — Multi-Photon Imaging
- Decision date
- 2023-12-22
- Date received
- 2023-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain
Also available from FDA: K232789.pdf
Official FDA record: K232789
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.