Clearance Summary
ELLIPSE 12PL, MODEL 9ESL7228 received FDA 510(k) clearance under submission number K060516, sponsored by Danish Dermatologic Development A/S. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2006-05-15.
- Submission: K060516
- Applicant / Sponsor: Danish Dermatologic Development A/S
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2006-05-15
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.