The following data is part of a premarket notification filed by Qualimed Srl with the FDA for Desio (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (clear And Tinted).
| Device ID | K142384 |
| 510k Number | K142384 |
| Device Name: | DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear And Tinted) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | QUALIMED SRL PIAZZA DELLA RADIO 37 Rome, IT 00146 |
| Contact | Tereza Uhrova |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 474 NE 61st PL Hillsboro, OR 97124 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-26 |
| Decision Date | 2014-12-12 |
| Summary: | summary |