VICTUS LASER PLATFORM— 510(k) K120426

Substantially Equivalent

Technolas Perfect Vision GmbH

FDA 510(k) clearance K120426 for VICTUS LASER PLATFORM, Substantially Equivalent on 2012-07-31. Applicant: Technolas Perfect Vision GmbH.

Clearance details

Applicant
Technolas Perfect Vision GmbH
Product code
Code OOE
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Francisco, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OOE

product code OOE
Injury
1,104
Malfunction
864
Total
1,968

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.