Identity
- Trade Name
- GENEO, GLO2FACIAL, ELITE FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Device Name
- RF PRO handpiece kit (formerly branded "TriPollar RF Applicator" kit) for GENEO X system (formerly branded "ELITE") in its USA Configuration (also abbreviated 'U'). FDA UDI
- Model / Reference
- RF PRO handpiece kit for GENEO X system (USA Configuration) FDA UDI
- Description
- RF PRO handpiece kit (formerly branded "TriPollar RF Applicator" kit) for GENEO X system (formerly branded "ELITE") in its USA Configuration (also abbreviated 'U'). FDA UDI
Identifiers
- Catalog Number
- 25000510E FDA UDI
- Primary DI / UDI-DI
- 07290016586671 FDA UDI
- 510(k) Number
- K233766 FDA UDI
- FDA Product Code
- PAY FDA UDI
- GMDN Term
- Multi-modality skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4420 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Geneo, Glo2facial, Elite by Pollogen Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pollogen Ltd
Sources (1)
- FDA UDI d3f64b5d-4b9b-431b-ba1b-239b255a9e40 36 fields · synced Jun 1, 2026