Soflex Limited · Class II · Cleared Mar 19, 2013
| K-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 |
| Applicant | Soflex Limited |
| Product code | LPL |
| Device class | Class II |
| Decision date | Mar 19, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 886.5925 |
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