Identity
- Trade Name
- POLLOGEN LEGEND FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system FDA UDI
- Device Name
- Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No.3 is indicated for the treatment of very small facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, also consisting of a plastic body with integrated electronic system, 3 electrodes and indication light guide ring. FDA UDI
- Model / Reference
- POLLOGEN LEGEND+ FDA UDI
- Description
- Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No.3 is indicated for the treatment of very small facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, also consisting of a plastic body with integrated electronic system, 3 electrodes and indication light guide ring. FDA UDI
Identifiers
- Catalog Number
- 21400370 FDA UDI
- Primary DI / UDI-DI
- 07290016586039 FDA UDI
- 510(k) Number
- K111026 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Category: Radio-frequency skin surface treatment system
Pollogen Legend by Pollogen Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111026 also covers:
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 d994ec83-0d15-453a-89e0-d1bb5bcf7e9c 35 fields · synced May 31, 2026