The following data is part of a premarket notification filed by Solotica with the FDA for Hidrocor, Hidrocharme, And Natural Colors.
| Device ID | K160472 |
| 510k Number | K160472 |
| Device Name: | Hidrocor, Hidrocharme, And Natural Colors |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | SOLOTICA R DOMINGOS FASOLARI 110 -CASA VERDE Sao Paulo, BR 02513-010 |
| Contact | Gilberto Zablith |
| Correspondent | Ray Kelly LICENSALE INC 57 LAZY BROOK RD Monroe, CT 06468 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-08-10 |