Identity
- Trade Name
- Legend Pro FDA UDI
- Generic Name
- Radio-frequency skin surface treatment/fat liquefaction system control unit FDA UDI
- Device Name
- LEGEND PRO PACKED 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
- Legend Pro FDA UDI
- Description
- LEGEND PRO PACKED 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
- 30020000U FDA UDI
- Primary DI / UDI-DI
- 07290016586138 FDA UDI
- 510(k) Number
- K173503 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment/fat liquefaction system control unit 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
Yes
FDA UDI
Category: Radio-frequency skin surface treatment/fat liquefaction system control unit
Legend Pro by Pollogen Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin surface treatment/fat liquefaction system control unit.
- EmFace or Evoke — Inmode MD , Ltd. · Class II
- Face Applicator (Cheek Right) — Inmode MD , Ltd. · Class II
- Face Applicator (Cheek Left ) — Inmode MD , Ltd. · Class II
- Chin Applicator — Inmode MD , Ltd. · Class II
- Define System — Inmode MD , Ltd. · Class II
- TriLift — POLLOGEN LTD · Class II
Cleared under the same submission
K173503 also covers:
- Hybrid Energy (HE) disposable tips — POLLOGEN LTD
- Hybrid Energy (HE) disposable tips — POLLOGEN LTD
- Legend Pro — POLLOGEN LTD
- Legend Pro — POLLOGEN LTD
- Legend Pro — POLLOGEN LTD
- Legend Pro — POLLOGEN LTD
- Legend Pro Hybrid Energy (HE) disposable tips — POLLOGEN LTD
- Legend Pro Hybrid Energy (HE) disposable tips — POLLOGEN LTD
- Legend Pro TriFractional (TF) disposable tips — POLLOGEN LTD
- TriFractional (TF) disposable tips — POLLOGEN LTD
- TriLift — POLLOGEN LTD
- triFX — POLLOGEN LTD
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 0dc4f0c3-4b91-43cb-b59c-56b5c6464550 35 fields · synced May 31, 2026