The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Visalis V500, Visalis S500.
| Device ID | K193376 |
| 510k Number | K193376 |
| Device Name: | Visalis V500, Visalis S500 |
| Classification | Unit, Phacofragmentation |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE 07745 |
| Contact | Katrin Faber |
| Correspondent | Katrin Faber Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE 07745 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-05 |
| Decision Date | 2020-06-15 |