510(k) K150907— Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

Substantially Equivalent

Ellipse A/S

Clearance details

Applicant: Ellipse A/S
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2015-04-03
Decision date: 2015-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoersholm, DK

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.