The following data is part of a premarket notification filed by Eyemed Technologies S.r.l. with the FDA for Adore (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (tinted/color).
| Device ID | K181656 |
| 510k Number | K181656 |
| Device Name: | ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Eyemed Technologies S.r.l. Via Al Boscaccio 3 Casorate Sempione, IT 21011 |
| Contact | Franco Ceravolo |
| Correspondent | Franco Ceravolo Eyemed Technologies S.r.l. Via Al Boscaccio 3 Casorate Sempione, IT 21011 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-22 |
| Decision Date | 2019-03-05 |
| Summary: | summary |