Clearance Summary
ELLIPSE JUVIA, MODEL 9EJU7465 received FDA 510(k) clearance under submission number K072023, sponsored by Ellipse A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2007-09-12.
- Submission: K072023
- Applicant / Sponsor: Ellipse A/S
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2007-09-12
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.