K103031 is an FDA 510(k) clearance for the BMR FACE. This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II - Special Controls, product code NFO).
Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on November 10, 2011, 394 days after receiving the submission on October 12, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K103031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2010 |
| Decision Date | November 10, 2011 |
| Days to Decision | 394 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |