Ulthera System (UC-1 Control Unit PRIME)
Ulthera, Inc.
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 |
| 3006560326 | 3006560326 | ULTHERA, INC. | 1 | N | 2020-04-25 | 1840 South Stapley Drive Suite 200 Mesa AZ US 85204 |
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 |
| 108624 | 1214468738 | K192185 | The Cellfina System | OUP | 2019-10-09 |
| 185073 | 1575368513 | K180623 | Ulthera System | OHV | 2018-05-04 |
| 108624 | 1611324236 | K180623 | Ulthera System | OHV | 2018-05-04 |
| 108624 | 1151622171 | K161885 | The Cellfina System | OUP | 2016-10-05 |
| 108624 | 1638176166 | K153677 | The Cellfina System | OUP | 2016-02-25 |
| 108624 | 1895339088 | K150505 | Cellfina System | OUP | 2015-07-29 |
| 108624 | 1730103060 | K134032 | ULTHERA SYSTEM | OHV | 2014-06-20 |
| 185073 | 1883245042 | K134032 | ULTHERA SYSTEM | OHV | 2014-06-20 |
| 108624 | 1027703479 | K134010 | CABOCHON SYSTEM | OUP | 2014-04-14 |
| 108624 | 1654802618 | K132028 | ULTHERA SYSTEM | OHV | 2013-12-11 |
| 185073 | 2023784269 | K132028 | ULTHERA SYSTEM | OHV | 2013-12-11 |
| 108624 | 1419280429 | K122528 | ULTHERA SYSTEM | OHV | 2012-08-28 |
| 185073 | 1757110497 | K122528 | ULTHERA SYSTEM | OHV | 2012-08-28 |
| 185073 | 1634543186 | K121700 | ULTHERA SYSTEM | OHV | 2012-10-02 |
| 108624 | 1848735973 | K121700 | ULTHERA SYSTEM | OHV | 2012-10-02 |
| 108624 | 1613630550 | DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 | OHV | 2009-09-11 |
| 185073 | 1734812242 | DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 | OHV | 2009-09-11 |
| 108624 | 1314469079 |
Product Codes Associated With Registrations#
PMN#
The Cellfina System
Ulthera, Inc
Ulthera System
Ulthera, Inc
The Cellfina System
ULTHERA, INC.
The Cellfina System
ULTHERA, INC.
Cellfina System
ULTHERA, INC.
ULTHERA SYSTEM
ULTHERA, INC.
ULTHERA SYSTEM
ULTHERA, INC.
ULTHERA SYSTEM
ULTHERA, INC.
ULTHERA SYSTEM
ULTHERA, INC.
GUDID#
Ulthera System Control Unit - UC-1 Rev. A
2016-09-07
Ulthera System Handpiece - UH-2 Rev N
2018-04-27
Ulthera System Control Unit - UC-1 Rev R
2018-04-27
Ulthera System Handpiece - UH-2 Rev. J
2016-12-14
Ulthera System Handpiece - UH-2 Rev. I
2016-12-14
Ulthera System Handpiece - UH-2 Rev. 1
2017-05-23
Ulthera System - UC-1 Rev 1
2017-05-23
Ulthera System Handpiece - UH-2 Rev. H
2016-12-14
Ulthera System Handpiece - UH-2 Rev. G
2016-12-14
Ulthera System Handpiece - UH-2 Rev. F
2016-12-14
Ulthera System Handpiece - UH-2 Rev. E
2016-09-06
Ulthera System Handpiece - UH-2 Rev. D
2016-09-06
Ulthera System Handpiece - UH-2 Rev. C
2016-09-06
Ulthera System Handpiece - UH-2 Rev. B
2017-05-23
Ulthera System Control Unit - UC-1 Rev. K
2016-09-07
Ulthera System Handpiece - UH-2 Rev. A
2017-05-23
Ulthera System Control Unit - UC-1 Rev. B
2016-09-07
Ulthera System Control Unit - UC-1 Rev. C
2016-09-07
Ulthera System Control Unit - UC-1 Rev. D
2016-09-07
Ulthera System Control Unit - UC-1 Rev. E
2016-09-07
Ulthera System Control Unit - UC-1 Rev. F
2016-09-07
Ulthera System Control Unit - UC-1 Rev. G
2016-09-07
Ulthera System Control Unit - UC-1 Rev. H
2016-09-07
Ulthera System Control Unit - UC-1 Rev. I
2016-09-07
Ulthera System Control Unit - UC-1 Rev. J
2016-09-07
Ulthera System Control Unit - UC-1 Rev. L
2016-09-07
Ulthera System Cart - UR-1 Rev. A
2024-05-21
Ulthera System Transducer - UT-3 Rev. G
2016-12-14
Cellfina System Procedure Kit (Single Package) - CK1-1 Rev. A
2016-12-12
Ulthera System Control Unit PRIME - UC-1 Control Unit (PRIME) Rev. A
2024-04-10
Ulthera System Handpiece - UH-2 DS 2.0 Rev A
2024-04-08
Ulthera System Transducer DS 7-3.0 - UT-1 Rev G
2019-07-18
Ulthera System Transducer - UT-1N Rev. G
2016-12-14
Ulthera System Transducer - UT-2 Rev. I
2016-12-14
Cellfina System Disposable Procedure Kit - Rev O
2019-03-18
Cellfina System Disposable Tray - CK1 Rev J
2019-07-18
Cellfina System Disposable Tray - CK1 rev E
2019-07-18
Cellfina - CK1-EU Rev A
2016-12-14
Cellfina Motor Module Device and Package - EU part should not have been registered with GUDID
2016-12-14
Cellfina Motor Module Device and Package - DI mis issued - not in use
2016-09-07