K131542 - NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC (FDA 510(k) Clearance)

K131542 is an FDA 510(k) clearance for the NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Novabay Pharmaceuticals, Inc. (Chevy Chase, US). The FDA issued a Cleared decision on July 24, 2013 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Novabay Pharmaceuticals, Inc. devices