The following data is part of a premarket notification filed by Qualimed Srl with the FDA for Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (clear And Tinted).
| Device ID | K181050 |
| 510k Number | K181050 |
| Device Name: | Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear And Tinted) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Qualimed SRL Corso Sempione 176 Busto Arsizio, IT 21052 |
| Contact | Tereza Uhrova |
| Correspondent | Bret Andre EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-20 |
| Decision Date | 2018-06-13 |
| Summary: | summary |