Cleared Traditional

K013732 - GELZONE

K013732 is the FDA 510(k) clearance for GELZONE by Implantech Associates, Inc.. It is a Class 1 General & Plastic Surgery device (product code MDA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013732 · Implantech Associates, Inc. · General & Plastic Surgery device
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Feb 2002
Decision
90d
Days
Class 1
Risk

K013732 is an FDA 510(k) clearance for the GELZONE. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on February 7, 2002 after a review of 90 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 Implantech Associates, Inc. devices

Submission Details

510(k) Number K013732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2001
Decision Date February 07, 2002
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K013732.
CURAD SCAR THERAPY
K024057 · Beiersdorf, Inc. · Jun 2003
NEOSPORIN SCAR SOLUTION
K024160 · Warner-Lambert Co. · Mar 2003
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · Smith & Nephew, Inc. · Jul 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · Smith & Nephew, Inc. · Jul 1999
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp. · Aug 1996