Cleared Special

K121559 - HYLATOPICPLUS LOTION

K121559 · Precision Dermatology Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
185d
Days
-
Risk

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.

View all Precision Dermatology Incorporated devices

FDA 510(k) Submission Details - K121559

510(k) Number K121559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2012
Decision Date November 30, 2012
Days to Decision 185 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 115d · This submission: 185d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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