The following data is part of a premarket notification filed by Micro Current Technology, Inc. with the FDA for Ultra Facial Toning System.
| Device ID | K181062 |
| 510k Number | K181062 |
| Device Name: | Ultra Facial Toning System |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Micro Current Technology, Inc. 2244 1st Ave. South Seattle, WA 98134 |
| Contact | David Suzuki |
| Correspondent | David Suzuki Regulatory Insight, Inc 2244 1st Ave. South Seattle, WA 98134 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-23 |
| Decision Date | 2018-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817076010884 | K181062 | 000 |
| 00817076010877 | K181062 | 000 |