ENHANCED ULTRA VIT PROBE— 510(k) K093305

Substantially Equivalent

Alcon Research, Ltd.

FDA 510(k) clearance K093305 for ENHANCED ULTRA VIT PROBE, Substantially Equivalent on 2010-04-02. Applicant: Alcon Research, Ltd..

Clearance details

Applicant
Alcon Research, Ltd.
Product code
Code MLZ
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MLZ

product code MLZ
Malfunction
692
Total
692

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.