The following data is part of a premarket notification filed by Unilens Corp., Usa with the FDA for Cvue Advanced Hydra Vue.
| Device ID | K121652 |
| 510k Number | K121652 |
| Device Name: | CVUE ADVANCED HYDRA VUE |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | UNILENS CORP., USA 10431 72ND ST. NORTH Largo, FL 33777 |
| Contact | Alan J Frazer |
| Correspondent | Alan J Frazer UNILENS CORP., USA 10431 72ND ST. NORTH Largo, FL 33777 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-05 |
| Decision Date | 2012-10-05 |
| Summary: | summary |