The following data is part of a premarket notification filed by Soflex Limited with the FDA for Eni-eye Sh Toric (efrofilcon A) Soft Hydrophilic Toric Contact Lens For Daily Wear, Multifocal Contact Lens, Keratoconus.
| Device ID | K110261 |
| 510k Number | K110261 |
| Device Name: | ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | SOFLEX LIMITED 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SOFLEX LIMITED 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-28 |
| Decision Date | 2011-07-28 |