| Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
| 510(k) Number |
K252218 |
| Device Name |
MF SC GEN2 Facial Toning System |
| Applicant |
| Micro Current Technology, Inc. |
| 2244 1st Ave. S. |
|
Seattle,
WA
98134
|
|
| Applicant Contact |
David Suzuki |
| Correspondent |
| Regulatory Technology Services, LLC |
| 1000 Westgate Dr. Suite #510k |
|
Saint Paul,
MN
55114
|
|
| Correspondent Contact |
Prithul Bom |
| Regulation Number | 882.5890 |
| Classification Product Code |
|
| Date Received | 07/15/2025 |
| Decision Date | 07/18/2025 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Statement |
Statement
|
| Type |
Special
|
| Reviewed by Third Party |
Yes
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|