510(k) K242227
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2025
- Date Received
- July 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4420
- Review Panel
- SU
- Submission Type
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.