Data / Medical devices / United States / Carl Zeiss Meditec Cataract Technology Inc
Carl Zeiss Meditec Cataract Technology Inc: FDA-registered device maker in Reno, NV, United States, 4 510(k) clearances
Carl Zeiss Meditec Cataract Technology Inc is registered with the FDA (registration 3012123033) in Reno, NV, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 8, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012123033
- Address
- 8740 Technology Way, Reno, NV, United States, 89521
- Owner or operator
- Carl Zeiss Meditec AG (Jena) (9053564)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 29, 1999
- Registered through
- 2026
- Brand names listed
- MACKOOL HOOKS, MICOR 700 with Auto I/A, MICOR Lens Fragmentation System, miCOR, miCOR (xPORT304; miCOR 700 system), miLOOP SU, miLOOP reusable
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hook, Ophthalmic | HNQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 2 | Manufacturer | accessdata.fda.gov |
| Vitrectomy, Instrument Cutter | MLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2025 | K243395 | MICOR 700 with Auto I/A | HQC | Substantially Equivalent | Carl Zeiss Meditec Cataract Technology, Inc. | accessdata.fda.gov |
| September 9, 2022 | K214028 | MICOR Lens Fragmentation System | HQC | Substantially Equivalent | Carl Zeiss Meditec Cataract Technology, Inc. | accessdata.fda.gov |
| August 24, 2022 | K222236 | miCOR System Lens Fragmentation System | HQC | Substantially Equivalent | Carl Zeiss Meditec Cataract Technology, Inc. | accessdata.fda.gov |
| July 31, 2020 | K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | HQC | Substantially Equivalent | Carl Zeiss Meditec Cataract Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Phacofragmentation
- All makers of Vitrectomy, Instrument Cutter
- All makers of Hook, Ophthalmic
Updated August 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.