PAY · Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
General, Plastic Surgery · 21 CFR 878.4420 · Class 2
Overview
| Product Code | PAY |
|---|---|
| Device Name | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Regulation | 21 CFR 878.4420 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters. (2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use. (3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use. (4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Instructions for cleaning the device must be validated. (7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device. (8) Software verification, validation, and hazard analysis must be performed. (9) Labeling must include: (i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users. (ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known. (iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | Jan 6, 2026 | SESE |
| K242227 | GENEO X ELITE | Pollogen, Ltd. | Oct 12, 2025 | SESE |
| K240616 | FAQ (102) | Foreo, Inc. | Jul 15, 2024 | SESE |
| K233766 | Geneo X Elite | Pollogen, Ltd. | May 7, 2024 | SESE |
| K232424 | CurrentBody Skin RF | El Global Trade, Ltd. | Mar 6, 2024 | SESE |
| K230013 | Silk'n Titan Allways | Silk'N Beauty , Ltd. | Aug 30, 2023 | SESE |
| K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | May 4, 2023 | SESE |
| K222012 | FAQ 101 | Foreo, Inc. | Apr 5, 2023 | SESE |
| K203665 | STOP U Model UXV Device | Pollogen, Ltd. | Feb 25, 2021 | SESE |
| K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen, Ltd. | Jun 19, 2019 | SESE |
| K170499 | sensiLift | El Global Trade, Ltd. | Jun 15, 2017 | SESE |
| DEN150005 | Newa Skin Therapy System | Endymed Medical, Ltd. | Dec 18, 2015 | DENG |
Top Applicants
- Pollogen, Ltd. — 5 clearances
- El Global Trade, Ltd. — 3 clearances
- Foreo, Inc. — 2 clearances
- Silk'N Beauty , Ltd. — 1 clearance
- Endymed Medical, Ltd. — 1 clearance
