Definition: Over-the-counter Treatment Of Wrinkles And Rhytides.
| Device Type ID | 5855 |
| Device Name | Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Physical State | Radiofrequency Current Generator And Electrode Applicators |
| Technical Method | Radiofrequency Electrical Current (i.e., Electrosurgical Device) |
| Target Area | Skin Wrinkles And Rhytides |
| Regulation Description | Electrosurgical Device For Over-the-counter Aesthetic Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4420 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PAY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5855 |
| Device | Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Product Code | PAY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Device For Over-the-counter Aesthetic Use. |
| CFR Regulation Number | 878.4420 [🔎] |