510(k) DEN080006
DEN080006 is an FDA 510(k) premarket notification submitted by Ulthera, Inc. for the device "ULTHERA SYSTEM, MODEL 8850-0001". The FDA issued a decision of De Novo Granted on September 11, 2009. The device falls under product code OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption), a Class II device regulated under 21 CFR 878.4590. Ulthera, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 11, 2009
- Date Received
- April 11, 2008
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- Device Class
- Class II
- Regulation Number
- 878.4590
- Review Panel
- SU
- Submission Type
A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.