DEN080006 is an FDA 510(k) submission for the ULTHERA SYSTEM, MODEL 8850-0001. This device is classified as a Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (Class II - Special Controls, product code OHV).
Submitted by Ulthera, Inc. (Mesa, US). The FDA issued a Not Cleared (DENG) decision on September 11, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4590. 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..
| 510(k) Number | DEN080006 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 11, 2008 |
| Decision Date | September 11, 2009 |
| Days to Decision | 518 days |
| Submission Type | Post-NSE |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | OHV - Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4590 |
| Definition | 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. |