K200584 is an FDA 510(k) clearance for the xPORT 304 (miCOR) System Lens Fragmentation System. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Carl Zeiss Meditec Cataract Technology, Inc. (Reno, US). The FDA issued a Cleared decision on July 31, 2020, 147 days after receiving the submission on March 6, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K200584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2020 |
| Decision Date | July 31, 2020 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |