Clearance Summary
ULTHERA SYSTEM, MODEL 8850-0001 received FDA 510(k) clearance under submission number DEN080006, sponsored by Ulthera, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-09-11.
- Submission: DEN080006
- Applicant / Sponsor: Ulthera, Inc.
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4590
- Decision date: 2009-09-11
Classification & Regulation
This clearance is catalogued under FDA product code OHV and 21 CFR 878.4590, within the General, Plastic Surgery review panel as a Class II device.