Identity
- Trade Name
- Legend Pro FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system applicator FDA UDI
- Device Name
- Legend Pro VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin. FDA UDI
- Model / Reference
- Legend Pro FDA UDI
- Description
- Legend Pro VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin. FDA UDI
Identifiers
- Catalog Number
- 20900330U FDA UDI
- Primary DI / UDI-DI
- 07290016586176 FDA UDI
- 510(k) Number
- K173503 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system applicator 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 applicator
Legend Pro by Pollogen Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radio-frequency skin surface treatment system applicator.
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- Transform (T3 Applicator) — Inmode MD , Ltd. · Class II
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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 0244a49e-bbb3-4fbd-ac4d-ac1bd2406099 35 fields · synced Jun 1, 2026