# K981387: Evanesce Scar Management System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Scientific, Inc.
- Decided: Jun 10, 1998 after 55 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 K971468 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971468: Scar Heal, Specialty Systems, Inc. (1997) Summary page 2.

## Indications for use
The Evanesce Scar Management System is intended for the over the counter topical management of Hypertrophic and Keloid Scars

Source page: https://510kreport.com/device/K981387
Methodology: https://510kreport.com/methodology