Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K181062 |
Device Name |
Ultra Facial Toning System |
Applicant |
Micro Current Technology, Inc. |
2244 1st Ave. South |
Seattle,
WA
98134
|
|
Applicant Contact |
David Suzuki |
Correspondent |
Regulatory Insight, Inc |
2244 1st Ave. South |
Seattle,
WA
98134
|
|
Correspondent Contact |
David Suzuki |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 04/23/2018 |
Decision Date | 07/18/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|