The following data is part of a premarket notification filed by Innova Vision Inc. with the FDA for I-lux Innova Blue Tint Lens, Model Super O2.
| Device ID | K033136 |
| 510k Number | K033136 |
| Device Name: | I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | INNOVA VISION INC. 3892 SOUTH AMERICA WEST TRAIL Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich INNOVA VISION INC. 3892 SOUTH AMERICA WEST TRAIL 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 | 2003-09-30 |
| Decision Date | 2004-03-05 |
| Summary: | summary |