Cleared Traditional

K120730 - LOUTREX TOPICAL CREAM

K120730 · Acella Pharmaceuticals, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
181d
Days
-
Risk

K120730 is an FDA 510(k) clearance for the LOUTREX TOPICAL CREAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acella Pharmaceuticals, LLC (Lake Wiley, US). The FDA issued a Cleared decision on September 6, 2012 after a review of 181 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K120730

510(k) Number K120730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2012
Decision Date September 06, 2012
Days to Decision 181 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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K120730 · LOUTREX TOPICAL CREAM
Download PDF FDA Summary Acella Pharmaceutical…