K250519
- 510(k) number
- K250519
- Device name
- Lap.Ox Laparoscopic Tissue Oximeter
- Applicant
- ViOptix, Inc. CA · US
- Product code
- MUD — Oximeter, Tissue Saturation
- Decision date
- 2025-06-26
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250519.pdf
Official FDA record: K250519
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.