# K984213: Nearly ME Retouch Silicone Scar Reduction Sheets

- Pathway: 510(k) (Traditional)
- Applicant: Capital Marketing Technologies, Inc.
- Decided: Apr 14, 1999 after 141 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 no predicate by number.

## Indications for use
NEARLY ME(R) RETOUCH(TM) Silicone Scar Reduction Sheets are soft durable silicone sheets designed to be worn on the skin for limited periods of time to reduce the appearance of hypertrophic and keloid scars.

Source page: https://510kreport.com/device/K984213
Methodology: https://510kreport.com/methodology