MODEL VISULAS 532S LASER WITH THE VITE OPTION— 510(k) K100035
Substantially EquivalentCarl Zeiss Meditec, AG
FDA 510(k) clearance K100035 for MODEL VISULAS 532S LASER WITH THE VITE OPTION, Substantially Equivalent on 2010-03-17. Applicant: Carl Zeiss Meditec, AG.
Clearance details
- Applicant
- Carl Zeiss Meditec, AG
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dublin, CA, US
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
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.