510(k) K242227
K242227 is an FDA 510(k) premarket notification submitted by Pollogen, Ltd. for the device "GENEO X ELITE". The FDA issued a decision of Substantially Equivalent on October 12, 2025. The device falls under product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4420. Pollogen, Ltd. has at least 10 other 510(k) clearances on record.
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.