Ulthera Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1012187 | 1012187 | Ulthera Inc | 1 | N | 2026-01-01 | 6501 Six Forks Rd Raleigh NC US 27615 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 185073 | 1887406603 | K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | OHV | 2025-05-13 |
| 185073 | 1479527053 | K243035 | Ulthera® System | OHV | 2025-02-24 |
| 185073 | 1175871584 | K233996 | Ulthera System (UC-1 Control Unit PRIME) | OHV | 2024-02-22 |
| 185073 | 1575368513 | K180623 | Ulthera System | OHV | 2018-05-04 |
| 185073 | 1883245042 | K134032 | ULTHERA SYSTEM | OHV | 2014-06-20 |
| 185073 | 2023784269 | K132028 | ULTHERA SYSTEM | OHV | 2013-12-11 |
| 185073 | 1757110497 | K122528 | ULTHERA SYSTEM | OHV | 2012-08-28 |
| 185073 | 1634543186 | K121700 | ULTHERA SYSTEM | OHV | 2012-10-02 |
| 185073 | 1734812242 | DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 | OHV | 2009-09-11 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OHV | 9 | 2025-05-13 |