Ulthera System (UC-1 Control Unit PRIME)
Ulthera, Inc.
ULTHERA, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 108624 | 1214468738 | K192185 | The Cellfina System | OUP | 2019-10-09 |
| 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 |
| 108624 | 1027703479 | K134010 | CABOCHON SYSTEM | OUP | 2014-04-14 |
| 108624 | 1654802618 | K132028 | ULTHERA SYSTEM | OHV | 2013-12-11 |
| 108624 | 1419280429 | K122528 | ULTHERA SYSTEM | OHV | 2012-08-28 |
| 108624 | 1848735973 | K121700 | ULTHERA SYSTEM | OHV | 2012-10-02 |
| 108624 | 1613630550 | DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 | OHV | 2009-09-11 |
| 108624 | 1314469079 |
Product Codes Associated With Registrations#
PMN#
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. 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. K
2016-09-07
Ulthera System Control Unit - UC-1 Rev. L
2016-09-07
Ulthera System Handpiece - UH-2 Rev. B
2017-05-23
Ulthera System Handpiece - UH-2 Rev. C
2016-09-06
Ulthera System Handpiece - UH-2 Rev. D
2016-09-06
Ulthera System Handpiece - UH-2 Rev. E
2016-09-06
Ulthera System Handpiece - UH-2 Rev. F
2016-12-14
Ulthera System Handpiece - UH-2 Rev. G
2016-12-14
Ulthera System Handpiece - UH-2 Rev. H
2016-12-14
Ulthera System - UC-1 Rev 1
2017-05-23
Ulthera System Handpiece - UH-2 Rev. 1
2017-05-23
Ulthera System Handpiece - UH-2 Rev. I
2016-12-14
Ulthera System Handpiece - UH-2 Rev. J
2016-12-14
Ulthera System Control Unit - UC-1 Rev R
2018-04-27
Ulthera System Handpiece - UH-2 Rev N
2018-04-27
Ulthera System Cart - UR-1 Rev. A
2024-05-21
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
Ulthera System Transducer - UT-3 Rev. G
2016-12-14
Ulthera System Transducer - UT-4 Rev. F
2016-08-12
Ulthera System Transducer - UT-4N Rev. F
2016-08-12
Cellfina Prep Pack for EU - CP1 Rev B
2016-12-12
Cellfina System Disposable Tray - CK1 Rev. F
2016-09-07
Cellfina Motor Module Device and Package - CM1 Rev B
2016-09-07
Cellfina Prep Pack - CP1 Rev C
2016-09-07