DeviceClearance

K081477

Substantially Equivalent

LUXTEC MLX LIGHT SOURCE

Applicant
Integra Luxtec, Inc.
Product code
FCW
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Boylston, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FCW

product code FCW
Malfunction
912
Other
1
Total
913

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.