Geneo X Elite
FDA 510(k) K233766 · Pollogen, Ltd.
510(k) numberK233766
Submission
- Device name
- Geneo X Elite
- Applicant
- Pollogen, Ltd.
Tel Aviv, IL - Received
- November 24, 2023
- Decision date
- May 7, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAY – Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4420
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code PAY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250341 | Sensilift Pro (ST300XXYYZZZ)PAY · Traditional | El Global Trade, Ltd. | 01/06/2026SE |
| K242227 | Geneo X ElitePAY · Traditional | Pollogen, Ltd. | 10/12/2025SE |
| K240616 | Faq (102)PAY · Traditional | Foreo, Inc. | 07/15/2024SE |
| K232424 | CurrentBody Skin RFPAY · Traditional | El Global Trade, Ltd. | 03/06/2024SE |
| K230013 | Silk'n Titan AllwaysPAY · Traditional | Silk'N Beauty , Ltd. | 08/30/2023SE |
| K220322 | Pollogen STOP U Model UXV DevicePAY · Traditional | Pollogen, Ltd. | 05/04/2023SE |
| K222012 | Faq 101PAY · Traditional | Foreo, Inc. | 04/05/2023SE |
| K203665 | STOP U Model UXV DevicePAY · Special | Pollogen, Ltd. | 02/25/2021SE |
| K182774 | STOP U (Packed Black USA), STOP U (Packed White USA)PAY · Traditional | Pollogen, Ltd. | 06/19/2019SE |
| K170499 | sensiLiftPAY · Traditional | El Global Trade, Ltd. | 06/15/2017SE |
More from El Global Trade, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242227 | Geneo X ElitePAY · Traditional | 10/12/2025SE |
| K252576 | Legend X PlatformGEI · Special | 09/12/2025SE |
| K250734 | OptiLUV DevicePBX · Traditional | 09/10/2025SE |
| K243217 | Legend X Desktop SystemGEI · Traditional | 11/01/2024SE |
| K240999 | Legend X Applicator VOGEI · Traditional | 05/08/2024SE |
| K232903 | Legend X PlatformGEI · Traditional | 10/17/2023SE |
| K220322 | Pollogen STOP U Model UXV DevicePAY · Traditional | 05/04/2023SE |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm TipsGEI · Special | 02/17/2022SE |
| K200545 | Legend Pro DMANGX · Traditional | 10/21/2021SE |
| K203665 | STOP U Model UXV DevicePAY · Special | 02/25/2021SE |
Questions and answers
When was Geneo X Elite cleared by the FDA?
Geneo X Elite (K233766) received a 510(k) decision of Substantially Equivalent on May 7, 2024, 165 days after the submission was received.
What is the product code of K233766?
The FDA product code is PAY – Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction, a Class II (moderate risk) device regulated under 21 CFR 878.4420.