K170499 is an FDA 510(k) clearance for the sensiLift. This device is classified as a Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction (Class II - Special Controls, product code PAY).
Submitted by El Global Trade, Ltd. (Netanya, IL). The FDA issued a Cleared decision on June 15, 2017, 118 days after receiving the submission on February 17, 2017.
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 | K170499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2017 |
| Decision Date | June 15, 2017 |
| Days to Decision | 118 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. |