Cleared Special

K121559 - HYLATOPICPLUS LOTION

K121559 · Precision Dermatology Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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

All 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K121559.
NIXALL TM WOUND AND SKIN CARE
K113693 · Seriously Clean, Ltd. · Dec 2012
L.A.M. IMP WOUND GEL
K123113 · Glycobiosciences, Inc. · Dec 2012
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K121361 · Curaline, Inc. · Nov 2012
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING
K120930 · Medtrade Products , Ltd. · Oct 2012
BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)
K113836 · Avery Dennison Belgie Bvba · Sep 2012
LOUTREX TOPICAL CREAM
K120730 · Acella Pharmaceuticals, LLC · Sep 2012
K121559 · HYLATOPICPLUS LOTION
Download PDF FDA Summary Precision Dermatology…