Clearance Summary
ELLIPSE FLEX PPT, MODEL 9ESF7255 received FDA 510(k) clearance under submission number K052688, 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 2005-12-12.
- Submission: K052688
- 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: 2005-12-12
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.