K252023 - MiraChlor Antimicrobial Wound Solution (FDA 510(k) Clearance)

K252023 is an FDA 510(k) clearance for the MiraChlor Antimicrobial Wound Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Letus Corporation (Happy Valley, US). The FDA issued a Cleared decision on March 25, 2026 after a review of 268 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Letus Corporation devices