The following data is part of a premarket notification filed by I-see Vision Technology Inc with the FDA for Ezvue (ocufilcon D) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K082879 |
| 510k Number | K082879 |
| Device Name: | EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | I-SEE VISION TECHNOLOGY INC 2904 N.BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich I-SEE VISION TECHNOLOGY INC 2904 N.BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2009-06-16 |
| Summary: | summary |