Cleared Traditional

K083718 - BEAU RX SCAR CARE GEL

K083718 is an FDA 510(k) clearance for BEAU RX SCAR CARE GEL, manufactured by Beau RX Solutions, LLC. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K083718 · Beau RX Solutions, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
42d
Days
Class 1
Risk

K083718 is an FDA 510(k) clearance for the BEAU RX SCAR CARE GEL. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Beau RX Solutions, LLC (Melbourne Beach, US). The FDA issued a Cleared decision on January 26, 2009 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beau RX Solutions, LLC devices

FDA 510(k) Submission Details - K083718

510(k) Number K083718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2008
Decision Date January 26, 2009
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 43
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K083718.
CURAD SCAR THERAPY
K024057 · Beiersdorf, Inc. · Jun 2003
NEOSPORIN SCAR SOLUTION
K024160 · Warner-Lambert Co. · Mar 2003
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.
K014036 · Medtrade Products , Ltd. · Feb 2002
GELZONE
K013732 · Implantech Associates, Inc. · Feb 2002
CONFORM SHEETING, MODEL IGEL
K012419 · Implantech Associates, Inc. · Oct 2001
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
K003979 · Medtrade Products , Ltd. · Mar 2001