FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
GENEO X ELITE
K Number: K242227
·
Decision Oct 12, 2025
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
11
Applicant Total
18
Review Days
439
Basic Information
- Device Name
- GENEO X ELITE
- K Number
- K242227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4420
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pollogen, Ltd.
- Date Received
- July 30, 2024
- Decision Date
- October 12, 2025
- Product Code
- PAY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Pollogen, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252576 | Legend X Platform | Sep 12, 2025 | Substantially Equivalent |
| K250734 | OptiLUV Device | Sep 10, 2025 | Substantially Equivalent |
| K243217 | Legend X Desktop System | Nov 1, 2024 | Substantially Equivalent |
| K240999 | Legend X Applicator VO | May 8, 2024 | Substantially Equivalent |
| K233766 | Geneo X Elite | May 7, 2024 | Substantially Equivalent |
| K232903 | Legend X Platform | Oct 17, 2023 | Substantially Equivalent |
| K220322 | Pollogen STOP U Model UXV Device | May 4, 2023 | Substantially Equivalent |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm Tips | Feb 17, 2022 | Substantially Equivalent |
| K200545 | Legend Pro DMA | Oct 21, 2021 | Substantially Equivalent |
| K203665 | STOP U Model UXV Device | Feb 25, 2021 | Substantially Equivalent |