The following data is part of a premarket notification filed by Soflex Limited with the FDA for Eni-eye Sh Soft K Semi Scleral (efrofilcon A) Soft (hydrophilic) Keratoconus And Irregular Cor Eni-eye Sh Soft K Toric S.
| Device ID | K122220 |
| 510k Number | K122220 |
| Device Name: | ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | SOFLEX LIMITED 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SOFLEX LIMITED 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2013-03-19 |