The following data is part of a De Novo classification by Ulthera, Inc. with the FDA for Ulthera System, Model 8850-0001.
| DeNovo ID | DEN080006 |
| Device Name: | ULTHERA SYSTEM, MODEL 8850-0001 |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | ULTHERA, INC. 33 South Sycamore Street Mesa, AZ 85202 |
| Contact | Randall E Miller |
| Product Code | OHV |
| CFR Regulation Number | 878.4590 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K072505 |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Post-NSE |
| Date Received | 2008-04-11 |
| Decision Date | 2009-09-11 |
| Reclassification Order: | Reclassification Order |