K082845 is an FDA 510(k) clearance for the INFINITI VISION SYSTEM WITH OZIL IP. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on February 12, 2009, 139 days after receiving the submission on September 26, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K082845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2008 |
| Decision Date | February 12, 2009 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |