# K990651: Skin 2 Forte Silicone Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: United Hospital Technologies, Inc.
- Decided: Aug 13, 1999 after 165 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 K974380 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974380: Rejuveness, Rejuveness Pharamceuticals, Inc. (1998) Summary page 1.

## Indications for use
SKIN 2 forté Silicone Sheeting is indicated for the management of hypertrophic and keloid scars. Consistent use of SKIN 2 forté can reduce hypertrophic and keloid scars. SKIN 2 forté may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic and keloid scars. SKIN 2 forté may be used as soon as the wound is closed, dry and the sutures or staples have been removed.

Source page: https://510kreport.com/device/K990651
Methodology: https://510kreport.com/methodology