# K991968: Cicacare Roll-on Gel-Scar Management Liquid Gel.

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 30, 1999 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
Longest line of descent: 2 generations back to K894226 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954413: Kelocote, Allied Biomedical Corp. (1995) Summary page 1.
- K960254: Silgel Topical Gel Sheet, Rofil Medical USA, Inc. (1996) Summary page 1.
- K974380: Rejuveness, Rejuveness Pharamceuticals, Inc. (1998) Summary page 1.
- (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 application to 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/K991968
Methodology: https://510kreport.com/methodology