ELLIPSE JUVIA, MODEL 9EJU7465— 510(k) K072023

Substantially Equivalent

Ellipse A/S

FDA 510(k) clearance K072023 for ELLIPSE JUVIA, MODEL 9EJU7465, Substantially Equivalent on 2007-09-12. Applicant: Ellipse A/S.

Clearance details

Applicant: Ellipse A/S
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2007-07-23
Decision date: 2007-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoersholm, DK

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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.