# K111733: Coreleader Scar-Dimmer

- Pathway: 510(k) (Traditional)
- Applicant: Coreleader Biotech Co., Ltd.
- Decided: Sep 22, 2011 after 93 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: 1 generation back to K935803 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003948: Epi-Derm Silicone Gel Sheeting, Biodermis Corp. (2001) Summary page 1.
- K935803: Cica-Care Silicone Gel Sheet, Smith & Nephew United, Inc. (1994) Summary page 1.

## Indications for use
Coreleader Scar-D Silicone Sheeting is intended for use: * for the management of closed hypertrophic and keloid scars.

Source page: https://510kreport.com/device/K111733
Methodology: https://510kreport.com/methodology