LOUTREX TOPICAL CREAM (K120730) - FDA 510(k) Clearance

K120730 is an FDA 510(k) clearance for the LOUTREX TOPICAL CREAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acella Pharmaceuticals, LLC (Lake Wiley, US). The FDA issued a Cleared decision on September 6, 2012 after a review of 181 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 Acella Pharmaceuticals, LLC devices