# K023678: Dimisil Scar Gel

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic and Reconstructive Technologies, Inc.
- Decided: Jan 23, 2003 after 83 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kelocote: named in the summary without a submission number
- (no number) Kelocote Scar Gel: named in the summary without a submission number

## Indications for use
The intended use of the AART, Inc. “DIMISIL Scar Gel” is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

Source page: https://510kreport.com/device/K023678
Methodology: https://510kreport.com/methodology