Device Classification Name |
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
|
510(k) Number |
K122528 |
Device Name |
ULTHERA SYSTEM |
Applicant |
ULTHERA, INC. |
1840 S Stapley Dr Suite 200 |
Mesa,
AZ
85204
|
|
Applicant Contact |
SUZON LOMMEL |
Correspondent |
ULTHERA, INC. |
1840 S Stapley Dr Suite 200 |
Mesa,
AZ
85204
|
|
Correspondent Contact |
SUZON LOMMEL |
Regulation Number | 878.4590
|
Classification Product Code |
|
Date Received | 08/20/2012 |
Decision Date | 08/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|