K240722 - Derma-R Cream (Derma-R Cream) (FDA 510(k) Clearance)

K240722 is an FDA 510(k) clearance for the Derma-R Cream (Derma-R Cream). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Raya Pharmaceuticals, LLC (Kingsland, US). The FDA issued a Cleared decision on September 20, 2024 after a review of 186 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 Raya Pharmaceuticals, LLC devices