# Rofil Medical USA, Inc.

- Location (FDA's records): Laguna Hills, CA
- FDA decisions: 1 (1996–1996): 1 510(k) clearance
- Product codes: MDA (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dow Corning Wright: 1 (https://510kreport.com/company/dow-corning-wright)

## Firms that cite its devices most
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K960254: Silgel Topical Gel Sheet (1996), cited by 1

## Recent decisions
- K960254: Silgel Topical Gel Sheet (Apr 2, 1996)

Source page: https://510kreport.com/company/rofil-medical-usa