510(k) · Cleared
ClearedCoreleader Scar-Dimmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coreleader Biotech Co., Ltd. · MDA Elastomer, Silicone, For Scar Management
Cleared on Sep 22, 2011 as substantially equivalent to K003948 (Biodermis Corp., 2001) and 1 other predicate after a 93-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 22, 2011
- Review
- 93 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935803 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK935803 Cica-Care Silicone Gel SheetSmith & Nephew United, Inc. · 1994
- This deviceK111733 Coreleader Scar-DimmerCoreleader Biotech Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935803 | Cica-Care Silicone Gel Sheet | Smith & Nephew United, Inc. | 1994 | — |
| 0 (this device) | K111733 | Coreleader Scar-Dimmer | Coreleader Biotech Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K003948 | Epi-Derm Silicone Gel SheetingSummary page 1…Silicone Sheeting Classification: Unclassified Classification Name: Elastomer, silicone, for scar management Predicate Device: BIODERMIS CORP, K003948, EPI-DERM SILICONE GEL SHEETING SMITH &NEPHEWUNITED, INC., K93 5803,… | 2001 |
| * | K935803 | Cica-Care Silicone Gel SheetSummary page 1…scar management Predicate Device: BIODERMIS CORP, K003948, EPI-DERM SILICONE GEL SHEETING SMITH &NEPHEWUNITED, INC., K93 5803, CICA-C ARE SILICONE GEL SHEET Device Description: Coreleader Scar-D silicone sheeting is a thin, soft… | 1994 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K003948.
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. 2011, 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?
Coreleader Scar-D Silicone Sheeting is intended for use:
* for the management of closed hypertrophic and keloid scars.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111733: Coreleader Scar-Dimmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111733
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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