510(k) · Cleared
ClearedBeau RX Scar Care Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beau RX Solutions, LLC · MDA Elastomer, Silicone, For Scar Management
Cleared on Jan 26, 2009 as substantially equivalent to K002488 (Advanced Bio-Technologies, Inc., 2001) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Jan 26, 2009
- Review
- 42 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002488 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002488 Kelo-Cote Topical GelAdvanced Bio-Technologies, Inc. · 2001
- 1 generation backK014036 Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp.…Medtrade Products, Ltd. · 2002
- This deviceK083718 Beau RX Scar Care GelBeau RX Solutions, LLC · 2009
- Descendant · cites it directly · 0 of its ownK131672 Microcyn Scar Management HydrogelOculus Innovative Sciences · 2013
Most influential descendants
Showing 1 of 1 · See all- K131672Microcyn Scar Management HydrogelOculus Innovative Sciences · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002488 | Kelo-Cote Topical Gel | Advanced Bio-Technologies, Inc. | 2001 | — |
| −1 | K014036 | Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin… | Medtrade Products, Ltd. | 2002 | — |
| 0 (this device) | K083718 | Beau RX Scar Care Gel | Beau RX Solutions, LLC | 2009 | — |
| +1 | K131672 | Microcyn Scar Management Hydrogel | Oculus Innovative Sciences | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MDA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002488 | Kelo-Cote Topical GelSummary page 1…are Gel, is substantially equivalent mn design, composition and function compared to Kelo-coteg Scar Gel manufactured by Advanced Bio-Technologies, Incorporated 510(k) # K002488 and Silicone Scar Gel manufactured by MedTrade Products, Limited 510(k) # K01 4036 4.1.6 Device Description: Beau RXTM Scar Care… | 2001 |
| * | K014036 | Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar…Summary page 1…to Kelo-coteg Scar Gel manufactured by Advanced Bio-Technologies, Incorporated 510(k) # K002488 and Silicone Scar Gel manufactured by MedTrade Products, Limited 510(k) # K01 4036 4.1.6 Device Description: Beau RXTM Scar Care Gel is a non sterile viscous emulsion/gel formulation, which is presented for over… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131672 | Microcyn Scar Management Hydrogel | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131672 (Oculus Innovative Sciences, 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K002488.
How does its category compare?
All MDA devicesMDA Elastomer, Silicone, For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MDA
2in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · MDA
Too few MDA 510(k)s in any year since 2007 to give a median.
Recalls per year · MDA
No recall names MDA since 2007.
Adverse event reports per year · MDA
3in 2025
MAUDE reports naming product code MDA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083718 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083718: Beau RX Scar Care Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083718
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026