# K984115: Scarease & Scarease Adhesive Gel

- Pathway: 510(k) (Traditional)
- Applicant: Scarease, Inc.
- Decided: Feb 12, 1999 after 87 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ScarEase is indicated for use in the management of hypertrophic and keloid scars. ScarEase is effective in the management of hypertrophic and keloid scars. Consistent use of ScarEase can reduce hypertrophic and keloid scarring. If used following surgical procedures, ScarEase may prevent hypertrophic and keloid scarring.

Source page: https://510kreport.com/device/K984115
Methodology: https://510kreport.com/methodology