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Oligio X

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243929

by Wontech Co., Ltd

Identifiers

510(k) Number
K243929 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)

Oligio X is a monopolar radiofrequency platform for deep dermal remodeling. It provides consistent, controllable heating with real-time temperature feedback for facial and body applications. The device safely coagulates skin tissues using radiofrequency energy.

The Oligio X is supplied as a medical device system and is FDA cleared. It is used for collagen remodeling and facial contouring through non-invasive radiofrequency treatment. The device operates at 6.78MHz frequency and is designed for anti-aging and tightening applications.

Frequently asked questions

What is the Oligio X device used for?

The Oligio X is a monopolar radiofrequency platform designed for deep dermal remodeling, collagen remodeling, and facial contouring through non-invasive radiofrequency treatment. It is used for anti-aging and tightening applications on both facial and body areas.

How is the Oligio X supplied and what are its specifications?

The Oligio X is supplied as a medical device system and operates at a frequency of 6.78MHz. It provides consistent, controllable heating with real-time temperature feedback for safe coagulation of skin tissues using radiofrequency energy.

Is the Oligio X a single-use device or can it be reused?

The device data does not specify whether the Oligio X is single-use or reusable. For information about device reusability, please consult the manufacturer's instructions for use or contact Wontech Co., Ltd. directly.

What is the regulatory status of the Oligio X device?

The Oligio X is FDA cleared with a 510(k) clearance number K243929. It was determined to be substantially equivalent to predicate devices and received a special clearance type through the General, Plastic Surgery advisory committee.

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: OLIGIO-X — Next-Generation Monopolar RF Platform | WONTECH USA, Online Store Coming Soon - wontech-usa.com, WONTECH - wtlaser-en.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wontech Co., Ltd
FDA Applicant
Wontech Co., Ltd.

Sources (1)

  • FDA 510(k) K243929 24 fields · synced Sep 21, 2026