xPORT 304 (miCOR) System Lens Fragmentation System— 510(k) K200584
Substantially EquivalentCarl Zeiss Meditec Cataract Technology, Inc.
FDA 510(k) clearance K200584 for xPORT 304 (miCOR) System Lens Fragmentation System, Substantially Equivalent on 2020-07-31. Applicant: Carl Zeiss Meditec Cataract Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec Cataract Technology, Inc.
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reno, NV, US
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More clearances from Carl Zeiss Meditec Cataract Technology, Inc.
view allAdverse 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.