The following data is part of a premarket notification filed by Carl Zeiss Meditec Cataract Technology Inc. with the FDA for Micor Lens Fragmentation System.
| Device ID | K214028 |
| 510k Number | K214028 |
| Device Name: | MICOR 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 | 2021-12-22 |
| Decision Date | 2022-09-09 |