# K991970: Scarease Sheets & Scarease Gel

- Pathway: 510(k) (Traditional)
- Applicant: Pillar Surgical
- Decided: Oct 25, 1999 after 136 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 K935499 (1994). 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)
- K974354: Mepiform Adherent Silicone Dressing for Scar Care, Sca Molnlycke (1998) Summary page 1.
- K935499: PMT Silicone Sheeting, Pmt Corp. (1994) Summary page 1.
- K974380: Rejuveness, Rejuveness Pharamceuticals, Inc. (1998) Summary page 1.
- K973572: Kelocote Scar Gel and Kelocote Laser Gel, Hanson Medical, Inc. (1997) Summary page 1.

## Indications for use
ScarEase Sheets and Gel are indicated for use in the management of hypertrophic and keloid scars. ScarEase Sheets and Gel may prevent hypertrophic and keloid scarring.

Source page: https://510kreport.com/device/K991970
Methodology: https://510kreport.com/methodology