Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K122711 |
Device Name |
FACIAL SPA |
Applicant |
NUSKIN |
ONE METRO CENTER 700 |
12TH STREET, SUITE 900 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
PAUL RUBIN |
Correspondent |
NUSKIN |
ONE METRO CENTER 700 |
12TH STREET, SUITE 900 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
PAUL RUBIN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 09/04/2012 |
Decision Date | 09/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|