Legend X Desktop System
FDA 510(k)Class II (US FDA 510(k))
by Pollogen Ltd
Identifiers
- 510(k) Number
- K243217 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Legend X Desktop System is a software-controlled electrosurgical device designed for dermatological and general surgical procedures. It features a desktop console with a touchscreen interface that regulates energy delivery through specialized handheld applicators, specifically the VO and TriPollar models.
This device is supplied as a desktop unit and has received FDA 510(k) clearance. It is classified under regulation number 878.4400 for use in general and plastic surgery applications.
Frequently asked questions
What is the primary function of the Legend X Desktop System?
The Legend X is a software-controlled electrosurgical device intended for use in dermatological and general surgical procedures. It utilizes a touchscreen interface to manage energy delivery through specific handheld applicators.
Which handheld applicators are compatible with this system?
The system is designed to regulate energy delivery through specialized handheld applicators, specifically the VO and TriPollar models.
What is the regulatory status of the Legend X Desktop System?
The Legend X Desktop System has received FDA 510(k) clearance under K-number K243217. It is classified under regulation number 878.4400 for use in general and plastic surgery applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K243217 FDA 510(k) - Legend X Desktop System | Pollogen, Ltd., Legend X Desktop System Clearance | Medical Device Navigator, Legend X Desktop System (K243217) — FDA 510(k) | Innolitics, Legend X Desktop System - BEUDAMED
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243217 | Class II | Active |
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Manufacturer
- Manufacturer
- Pollogen Ltd
- FDA Applicant
- Pollogen, Ltd.
Sources (1)
- FDA 510(k) K243217 24 fields · synced Sep 23, 2026