# K991957: Cicacare Management for Scars

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 20, 1999 after 40 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.
- (no number) Rejuveness: named in the summary without a submission number
- (no number) Clinicel: named in the summary without a submission number

## Indications for use
The device is intended for the management of hypertrophic and keloid scars. The device may prevent the formation of hypertrophic and keloid scars. The product is indicated for use only on intact skin. For covering Hypertrophic and Keloid Scars as a means of reducing the size and erythema of scars resulting from burns, trauma and surgery.

Source page: https://510kreport.com/device/K991957
Methodology: https://510kreport.com/methodology