K111446 is an FDA 510(k) clearance for the SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Abbott Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on December 21, 2011, 211 days after receiving the submission on May 24, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K111446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2011 |
| Decision Date | December 21, 2011 |
| Days to Decision | 211 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 |