The following data is part of a premarket notification filed by Ulthera, Inc. with the FDA for Ulthera System.
| Device ID | K132028 |
| 510k Number | K132028 |
| Device Name: | ULTHERA SYSTEM |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | ULTHERA, INC. 2150 S. Country Club Drive Suite 21 Mesa, AZ 85210 |
| Contact | Suzon Lommel |
| Correspondent | Suzon Lommel ULTHERA, INC. 2150 S. Country Club Drive Suite 21 Mesa, AZ 85210 |
| Product Code | OHV |
| CFR Regulation Number | 878.4590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2013-12-11 |
| Summary: | summary |