HYLATOPICPLUS LOTION (K121559) - FDA 510(k) Clearance

K121559 is an FDA 510(k) clearance for the HYLATOPICPLUS LOTION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Precision Dermatology Incorporated (Cumberland, US). The FDA issued a Cleared decision on November 30, 2012 after a review of 185 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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