miCOR System Lens Fragmentation System— 510(k) K222236
Substantially EquivalentCarl Zeiss Meditec Cataract Technology, Inc.
FDA 510(k) clearance K222236 for miCOR System Lens Fragmentation System, Substantially Equivalent on 2022-08-24. Applicant: Carl Zeiss Meditec Cataract Technology, Inc..
Clearance details
- Applicant
- Carl Zeiss Meditec Cataract Technology, Inc.
- Product code
- Code HQC
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Reno, NV, US
Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.