510(k) · Cleared
ClearedMicrocyn Scar Management Hydrogel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Innovative Sciences · PFP Silicone Hydrogel For Scar Management
Cleared on Nov 15, 2013 as substantially equivalent to K002488 (Advanced Bio-Technologies, Inc., 2001) and 1 other predicate after a 162-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Nov 15, 2013
- Review
- 162 days
- Class
- Class I
- Product code
- PFP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002488 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK002488 Kelo-Cote Topical GelAdvanced Bio-Technologies, Inc. · 2001
- 2 generations backK014036 Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp.…Medtrade Products, Ltd. · 2002
- 1 generation backK083718 Beau RX Scar Care GelBeau RX Solutions, LLC · 2009
- This deviceK131672 Microcyn Scar Management HydrogelOculus Innovative Sciences · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002488 | Kelo-Cote Topical Gel | Advanced Bio-Technologies, Inc. | 2001 | — |
| −2 | K014036 | Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin… | Medtrade Products, Ltd. | 2002 | — |
| −1 | K083718 | Beau RX Scar Care Gel | Beau RX Solutions, LLC | 2009 | — |
| 0 (this device) | K131672 | Microcyn Scar Management Hydrogel | Oculus Innovative Sciences | 2013 | — |
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 PFP? 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…FP Legally marketed device(s) Kelo-Cote TopicalTm Gel manufactured by Advanced Rio- to which equivalence is Technologies, cleared for distribution via 510(k) K002488 claimed: Beau Rx Scar Care Gel currently marketed as Atopiclair® m… | 2001 |
| * | K083718 | Beau RX Scar Care GelSummary page 1…rrently marketed as Atopiclair® manufactured by Beau Rx Solutions, LLC. cleared for distribution via 510(k) K083718 Reason for 510(k) New Device submission Device Description Microcyn® Scar Management HydroGel is a tr… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K002488.
How does its category compare?
All PFP devicesPFP Silicone Hydrogel For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PFP
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PFP
Too few PFP 510(k)s in any year since 2007 to give a median.
Recalls per year · PFP
No recall names PFP since 2007.
Adverse event reports per year · PFP
1in 2020
MAUDE reports naming product code PFP, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131672 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131672: Microcyn Scar Management Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131672
Report an extraction error
Are you the manufacturer?
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