DeviceClearance

MACH LED 2SC— 510(k) K140460

Substantially Equivalent

Dr. Mach GmbH & Co. KG

FDA 510(k) clearance K140460 for MACH LED 2SC, Substantially Equivalent on 2014-04-03. Applicant: Dr. Mach GmbH & Co. KG.

Clearance details

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