DeviceClearance

K140460

Substantially Equivalent

MACH LED 2SC

Applicant
Dr. Mach GmbH & Co. KG
Product code
FSY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Norderstedt, Schleswig-Holstein, DE
Download summary PDF View on FDA.gov ↗

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.