K240616 is an FDA 510(k) clearance for the FAQ™ (102). This device is classified as a Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction (Class II - Special Controls, product code PAY).
Submitted by Foreo, Inc. (Las Vegas, US). The FDA issued a Cleared decision on July 15, 2024, 132 days after receiving the submission on March 5, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 878.4420. An Electrosurgical Device For Over-the-counter Aesthetic Use Is A Device Using Radiofrequency Energy To Produce Localized Heating Within Tissues For Non-invasive Aesthetic Use..
| 510(k) Number | K240616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2024 |
| Decision Date | July 15, 2024 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | PAY - Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4420 |
| Definition | An Electrosurgical Device For Over-the-counter Aesthetic Use Is A Device Using Radiofrequency Energy To Produce Localized Heating Within Tissues For Non-invasive Aesthetic Use. |