Cleared Traditional

K111733 - CORELEADER SCAR-DIMMER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K111733 · Coreleader Biotech Co., Ltd. · General & Plastic Surgery device
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Sep 2011
Decision
93d
Days
Class 1
Risk

K111733 is an FDA 510(k) clearance for the CORELEADER SCAR-DIMMER. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Coreleader Biotech Co., Ltd. (New Taipei, Taiwan, TW). The FDA issued a Cleared decision on September 22, 2011 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - 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 Coreleader Biotech Co., Ltd. devices

Submission Details

510(k) Number K111733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2011
Decision Date September 22, 2011
Days to Decision 93 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
21d faster than avg
Panel avg: 114d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.