Cleared Traditional

CLEANE / CLEANE POP (K111341) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111341 · Medicon Co., Ltd. · General & Plastic Surgery device
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Feb 2012
Decision
293d
Days
Class 2
Risk

K111341 is an FDA 510(k) clearance for the CLEANE / CLEANE POP. Classified as Over The Counter Thermal Treatment For Acne. (product code OZC), Class II - Special Controls.

Submitted by Medicon Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on February 29, 2012 after a review of 293 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5740 - the FDA general and plastic surgery device framework. 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.

View all Medicon Co., Ltd. devices

Submission Details

510(k) Number K111341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2011
Decision Date February 29, 2012
Days to Decision 293 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 115d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OZC Over The Counter Thermal Treatment For Acne.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
Definition For The Treatment Of Mild To Moderate Inflammatory Acne.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.