SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION (K063069) - FDA 510(k) Clearance

K063069 is an FDA 510(k) clearance for the SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medical Molecular Therapuetics, LLC (Lakemont, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 280 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.

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