# K971009: Scar Care

- Pathway: 510(k) (Traditional)
- Applicant: Target Health, Inc.
- Decided: Jul 29, 1997 after 131 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 K913140 (1991). 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)
- K913140: Silicone Gel Sheeting, Cui Corp. (1991) Summary page 4.

## Indications for use
SCAR CARE™ is intended for use in the management of hypertrophic and keloid scars.

Source page: https://510kreport.com/device/K971009
Methodology: https://510kreport.com/methodology