MiraChlor Antimicrobial Wound Solution— 510(k) K252023
Substantially EquivalentLetus Corporation
FDA 510(k) clearance K252023 for MiraChlor Antimicrobial Wound Solution, Substantially Equivalent on 2026-03-25. Applicant: Letus Corporation. Device class: Unclassified.
Summary
Letus Corporation's MiraChlor Antimicrobial Wound Solution is filed under FRO, drug wound dressings. "Antimicrobial" is part of the product's name, and the record doesn't describe the solution beyond that name and code name.
The device class is listed as U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Traditional 510(k).
Letus filed from Happy Valley, Oregon. Review took 268 calendar days (June 30, 2025 to March 25, 2026).
Clearance details
- Applicant
- Letus Corporation
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Happy Valley, OR, US
Recent devices under product code FRO
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.