DeviceClearance

K992540

Substantially Equivalent

XENON LIGHT SOURCE PES 1

Applicant
Laser Optik Systeme GmbH & Co. KG
Product code
GCT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Germany, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code GCT

product code GCT
Malfunction
1,393
Other
2
Total
1,395

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.