# K971468: Scar Heal

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Systems, Inc.
- Decided: Jun 10, 1997 after 49 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K981387: Evanesce Scar Management System (1998), 0 descendants of its own

## Indications for use
Keloid Scars

Source page: https://510kreport.com/device/K971468
Methodology: https://510kreport.com/methodology