K252023 is an FDA 510(k) clearance for the MiraChlor Antimicrobial Wound Solution. This device is classified as a Dressing, Wound, Drug.
Submitted by Letus Corporation (Happy Valley, US). The FDA issued a Cleared decision on March 25, 2026, 268 days after receiving the submission on June 30, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K252023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2025 |
| Decision Date | March 25, 2026 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |