The following data is part of a premarket notification filed by Unilens Corp., Usa with the FDA for Cvue Advanced (hioxifilcon D) Soft (hydrophilic) Contact Lens.
| Device ID | K142851 |
| 510k Number | K142851 |
| Device Name: | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Unilens Corp., USA 10431 72nd Street North Largo, FL 33777 |
| Contact | Alan J. Frazer |
| Correspondent | Alan J. Frazer Unilens Corp., USA 10431 72nd Street North Largo, FL 33777 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2014-10-30 |
| Summary: | summary |