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. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 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. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 electrodes and indication light guide ring. FDA UDI
Identifiers
- Catalog Number
- 20900270 FDA UDI
- Primary DI / UDI-DI
- 07290016586015 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 c61e658e-dacc-4f89-a45f-7a0db423a560 35 fields · synced Jun 8, 2026