K111697 is an FDA 510(k) clearance for the AMO WHITESTAR SIGNATURE 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 September 27, 2011, 102 days after receiving the submission on June 17, 2011.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K111697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2011 |
| Decision Date | September 27, 2011 |
| Days to Decision | 102 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |