# MDA: Elastomer, Silicone, For Scar Management

- Device class: 1; regulation: 21 CFR 878.4025; FDA's rule: 510(k) exempt
- FDA decisions: 81
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 14
- 2000: 2
- 2001: 6
- 2002: 3
- 2003: 3
- 2004: 1
- 2005: 1
- 2006: 1
- 2009: 1
- 2011: 2

## Most-cited predicates
- K002488: Kelo-Cote Topical Gel (2001), cited by 4
- K974380: Rejuveness (1998), cited by 4
- K974354: Mepiform Adherent Silicone Dressing for Scar Care (1998), cited by 2
- K935803: Cica-Care Silicone Gel Sheet (1994), cited by 2
- K954413: Kelocote (1995), cited by 2
- K003948: Epi-Derm Silicone Gel Sheeting (2001), cited by 2
- K982036: Silon Scar Strips (1998), cited by 2
- K963128: Novagel Silicone Gel Sheeting (1996), cited by 1
- K971468: Scar Heal (1997), cited by 1
- K083718: Beau RX Scar Care Gel (2009), cited by 1

Source page: https://510kreport.com/product-code/MDA
Data by year (CSV): https://510kreport.com/product-code/MDA.csv