# K991312: Soothe & Smooth Scar Care - Silicone Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Library Medical, Inc.
- Decided: Aug 20, 1999 after 126 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.

## Indications for use
To be used in the management of Hypertrophic and Keloid scars that are the result of surgery, trauma, and burns. Also, LMI Scar Management Silicone Sheeting may prevent Hypertrophic and Keloid scars from forming.

Source page: https://510kreport.com/device/K991312
Methodology: https://510kreport.com/methodology