K233766 is an FDA 510(k) clearance for the Geneo X Elite. This device is classified as a Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction (Class II - Special Controls, product code PAY).
Submitted by Pollogen, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on May 7, 2024, 165 days after receiving the submission on November 24, 2023.
This device falls under the General & Plastic Surgery 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 | K233766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2023 |
| Decision Date | May 07, 2024 |
| Days to Decision | 165 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |