K181074 - Simple Science Antimicrobial Facial and Eyelid Cleanser (FDA 510(k) Clearance)

K181074 is an FDA 510(k) clearance for the Simple Science Antimicrobial Facial and Eyelid Cleanser. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Simple Science, LLC (Edina, US). The FDA issued a Cleared decision on August 17, 2018 after a review of 115 days - within the typical 510(k) review window.

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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