K193376 is an FDA 510(k) clearance for the Visalis V500, Visalis S500. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on June 15, 2020, 193 days after receiving the submission on December 5, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K193376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2019 |
| Decision Date | June 15, 2020 |
| Days to Decision | 193 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 |