Submission Details
| 510(k) Number | K252673 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 25, 2025 |
| Decision Date | December 22, 2025 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |