# Soflex Limited

- Location (FDA's records): Littleton, CO
- FDA decisions: 3 (2011–2013): 3 510(k) clearances
- Product codes: LPL (3)
- Predicates its devices cite: 0 (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 that cite its devices most
- Firestone Optics, Inc.: 1 (https://510kreport.com/company/firestone-optics)

## Its most-cited devices
- K122220: Eni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus and Irregular Cor Eni-Eye SH Soft K Toric S (2013), cited by 1

## Recent decisions
- K122220: Eni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus and Irregular Cor Eni-Eye SH Soft K Toric S (Mar 19, 2013)
- K122213: Eni-Eye SH Sphere (Efrofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear (Dec 12, 2012)
- K110261: Eni-Eye SH Toric (Efrofilcon a) Soft Hydrophilic Toric Contact Lens for Daily Wear, Multifocal Contact Lens, Keratoconus (Jul 28, 2011)

Source page: https://510kreport.com/company/soflex