Device Classification Name |
powered surgical instrument for improvement in the appearance of cellulite
|
510(k) Number |
K161885 |
Device Name |
The Cellfina System |
Applicant |
ULTHERA, INC. |
1840 S Stapley Drive, Suite 200 |
Mesa,
AZ
85204
|
|
Applicant Contact |
SUZON LOMMEL |
Correspondent |
ULTHERA, INC. |
1840 S Stapley Drive, Suite 200 |
Mesa,
AZ
85204
|
|
Correspondent Contact |
SUZON LOMMEL |
Regulation Number | 878.4790
|
Classification Product Code |
|
Date Received | 07/11/2016 |
Decision Date | 10/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01671839
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|