xPORT S Lens Fragmentation System— 510(k) K200207
Substantially EquivalentCarl Zeiss Meditec Cataract Technology, Inc.
FDA 510(k) clearance K200207 for xPORT S Lens Fragmentation System, Substantially Equivalent on 2020-10-15. Applicant: Carl Zeiss Meditec Cataract Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec Cataract Technology, Inc.
- Product code
- Product 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
Recent devices under product code HQC
view allMore clearances from Carl Zeiss Meditec Cataract Technology, Inc.
view all- K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
- K214028 — MICOR Lens Fragmentation System
- K222236 — miCOR System Lens Fragmentation System
- K200584 — xPORT 304 (miCOR) System Lens Fragmentation System
- K191024 — xPORT Lens Fragmentation System
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.