# K962013: Mentor H/S Silicone Gel Sheeting for Scar Management

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Aug 22, 1996 after 91 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. The FDA summary names its predicate without a number.
- (no number) DermaSof: named in the summary without a submission number
- (no number) Epi-Dem Silicone Gel Sheeting: named in the summary without a submission number
- (no number) TopiGel: named in the summary without a submission number
- (no number) Sil-K: named in the summary without a submission number

## Indications for use
The Mentor H/S Silicone Gel Sheeting for Scar Management is indicated for treatment of hypertropic and keloid scars. This therapy does not remove the scar but will flatten and soften the scar tissue as well as return a more natural palor to the scar area.

Source page: https://510kreport.com/device/K962013
Methodology: https://510kreport.com/methodology