# K980563: Skar-Kare Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Life Medical Sciences, Inc.
- Decided: May 20, 1998 after 96 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) REJUVENESS™ (formerly known as Silk*Skin): named in the summary without a submission number

## Indications for use
SKAR-KARE™_SHEET is indicated for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.

Source page: https://510kreport.com/device/K980563
Methodology: https://510kreport.com/methodology