K242227 is an FDA 510(k) clearance for the GENEO X ELITE, 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 October 12, 2025, 439 days after receiving the submission on July 30, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4420.
| 510(k) Number | K242227 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 30, 2024 |
| Decision Date | October 12, 2025 |
| Days to Decision | 439 days |
| Submission Type | Traditional |
| 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. |