K182774 is an FDA 510(k) clearance for the STOP U (Packed Black USA), STOP U (Packed White USA). 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 June 19, 2019, 261 days after receiving the submission on October 1, 2018.
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 | K182774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2018 |
| Decision Date | June 19, 2019 |
| Days to Decision | 261 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. |