The following data is part of a premarket notification filed by Carl Zeiss Meditec Cataract Technology Inc. with the FDA for Xport S Lens Fragmentation System.
| Device ID | K200207 |
| 510k Number | K200207 |
| Device Name: | XPORT S Lens Fragmentation System |
| Classification | Unit, Phacofragmentation |
| Applicant | Carl Zeiss Meditec Cataract Technology Inc. 8748 Technology Way Reno, NV 89521 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik Carl Zeiss Meditec Cataract Technology Inc. 8748 Technology Way Reno, NV 89521 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-28 |
| Decision Date | 2020-10-15 |