VICTUS Femtosecond Laser Platform— 510(k) K151161
Substantially EquivalentTechnolas Perfect Vision GmbH
FDA 510(k) clearance K151161 for VICTUS Femtosecond Laser Platform, Substantially Equivalent on 2015-06-24. 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
- München, DE
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.