K033136 is an FDA 510(k) clearance for the I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by Innova Vision, Inc. (Flagstaff, US). The FDA issued a Cleared decision on March 5, 2004, 157 days after receiving the submission on September 30, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K033136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2003 |
| Decision Date | March 05, 2004 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPL - Lenses, Soft Contact, Daily Wear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |