K183189 is an FDA 510(k) clearance for the Ultra OTC Facial Toning System. This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II - Special Controls, product code NFO).
Submitted by Micro Current Technology, Inc. (Seattle, US). The FDA issued a Cleared decision on April 17, 2019, 149 days after receiving the submission on November 19, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K183189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2018 |
| Decision Date | April 17, 2019 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | NFO - Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |