TRULIGHT 5520 AND TRULIGHT 5320— 510(k) K102758
Substantially EquivalentTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg
FDA 510(k) clearance K102758 for TRULIGHT 5520 AND TRULIGHT 5320, Substantially Equivalent on 2010-10-26. Applicant: Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg.
Clearance details
- Applicant
- Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
- Product code
- Code FSY
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charleston, SC, US
Adverse events under product code FSY
product code FSY- Malfunction
- 2,759
- Other
- 1
- Total
- 2,760
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.