The following data is part of a premarket notification filed by Unilens Corp., Usa with the FDA for Cvue Advanced Definitive.
| Device ID | K100456 |
| 510k Number | K100456 |
| Device Name: | CVUE ADVANCED DEFINITIVE |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | UNILENS CORP., USA 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing UNILENS CORP., USA 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2010-10-28 |
| Summary: | summary |