# K083718: Beau RX Scar Care Gel

- Pathway: 510(k) (Traditional)
- Applicant: Beau RX Solutions, LLC
- Decided: Jan 26, 2009 after 42 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002488 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002488: Kelo-Cote Topical Gel, Advanced Bio-Technologies, Inc. (2001) Summary page 1.
- K014036: Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar Therapy Gel, Model 09916030., Medtrade Products, Ltd. (2002) Summary page 1.

## Most influential descendants
- K131672: Microcyn Scar Management Hydrogel (2013), 0 descendants of its own

## Indications for use
The Beau RXTm Scar Care Gel is intended for'the management of old and new hypertrophic and keloid scarring on scars resulting for burns, general surgical procedures and trauma wounds

Source page: https://510kreport.com/device/K083718
Methodology: https://510kreport.com/methodology