Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K171588 |
Device Name |
NuBODY Skin Toning Device |
Applicant |
Carol Cole Company dba NuFACE |
1325 Sycamore Ave, Suite A |
Vista,
CA
92081
|
|
Applicant Contact |
Donald Ellis |
Correspondent |
Carol Cole Company dba NuFACE |
1325 Sycamore Ave, Suite A |
Vista,
CA
92081
|
|
Correspondent Contact |
Donald Ellis |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 05/31/2017 |
Decision Date | 07/31/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|