MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)— 510(k) K242801

Substantially Equivalent

Carl Zeiss Meditec Cataract Technology, Inc.

FDA 510(k) clearance K242801 for MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185), Substantially Equivalent on 2025-06-11. 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: 2024-09-17
Decision date: 2025-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.