Cleared Traditional

K991312 - SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING

K991312 is an FDA 510(k) clearance for SOOTHE & SMOOTH SCAR CARE - SILICONE SH..., manufactured by Library Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K991312 · Library Medical, Inc. · General & Plastic Surgery device
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Aug 1999
Decision
126d
Days
Class 1
Risk

K991312 is an FDA 510(k) clearance for the SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Library Medical, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 20, 1999 after a review of 126 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 Library Medical, Inc. devices

FDA 510(k) Submission Details - K991312

510(k) Number K991312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1999
Decision Date August 20, 1999
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

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

All 51
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K991312.
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
K003979 · Medtrade Products , Ltd. · Mar 2001
SPECTRUM DESIGNS SPECTRAGEL
K992522 · Spectrum Designs, Inc. · Oct 1999
SCAREASE SHEETS & SCAREASE GEL
K991970 · Pillar Surgical · Oct 1999
SKIN 2 FORTE SILICONE SHEETING
K990651 · United Hospital Technologies, Inc. · Aug 1999
SILGEL STC-S
K984029 · Nagor , Ltd. · Aug 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · Smith & Nephew, Inc. · Jul 1999