# K982036: Silon Scar Strips

- Pathway: 510(k) (Traditional)
- Applicant: Bio Med Sciences, Inc.
- Decided: Aug 6, 1998 after 57 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 K932214 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932214: Silon Silicone Gel Sheet, Bio Med Sciences, Inc. (1994) Summary page 1.
- K974380: Rejuveness, Rejuveness Pharamceuticals, Inc. (1998) Summary page 1.

## Most influential descendants
- K023136: Oleeva Fabric (2002), 1 descendant of its own
- K024160: Neosporin Scar Solution (2003), 0 descendants of its own

## Indications for use
Silon Scar Strips are indicated for the management of hypertrophic scars and keloids. Consistent use of Silon Scar Strips can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin. Silon Scar Strips may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.

Source page: https://510kreport.com/device/K982036
Methodology: https://510kreport.com/methodology