The following data is part of a premarket notification filed by Micro Current Technology, Inc. with the FDA for Ultra Otc Facial Toning System.
| Device ID | K183189 |
| 510k Number | K183189 |
| Device Name: | Ultra OTC 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 | Shelley Morandi Micro Current Technology, 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 | 2018-11-19 |
| Decision Date | 2019-04-17 |