PHACOFRAGMENTATION SYSTEM MEGATRON— 510(k) K002031

Substantially Equivalent

Asclepion-Meditec AG

FDA 510(k) clearance K002031 for PHACOFRAGMENTATION SYSTEM MEGATRON, Substantially Equivalent on 2000-12-27. Applicant: Asclepion-Meditec AG.

Clearance details

Applicant: Asclepion-Meditec AG
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2000-07-03
Decision date: 2000-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.