K230013 is an FDA 510(k) clearance for the Silk'n Titan Allways. This device is classified as a Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction (Class II - Special Controls, product code PAY).
Submitted by Silk'N Beauty , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on August 30, 2023, 239 days after receiving the submission on January 3, 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 | K230013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2023 |
| Decision Date | August 30, 2023 |
| Days to Decision | 239 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. |