Cleared Special

K110727 - HYLATOPICPLUS CREAM

K110727 · 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
Apr 2011
Decision
16d
Days
-
Risk

K110727 is an FDA 510(k) clearance for the HYLATOPICPLUS CREAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Precision Dermatology Incorporated (Cumberland, US). The FDA issued a Cleared decision on April 1, 2011 after a review of 16 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K110727

510(k) Number K110727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2011
Decision Date April 01, 2011
Days to Decision 16 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
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
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K110458 · Advanced Medical Solutions Limited · Mar 2011
K110727 · HYLATOPICPLUS CREAM
Download PDF FDA Summary Precision Dermatology…