K250519 is an FDA 510(k) clearance for the Lap.Ox? Laparoscopic Tissue Oximeter, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Vioptix, Inc. (Newark, US). The FDA issued a Cleared decision on June 26, 2025, 125 days after receiving the submission on February 21, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K250519 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 21, 2025 |
| Decision Date | June 26, 2025 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2700 |