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Oligio X

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240313

by Wontech Co., Ltd

Identifiers

510(k) Number
K240313 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 Oligio X is a monopolar radiofrequency (RF) device designed for deep dermal remodeling, classified under the product code GEI (General, Plastic Surgery). It delivers controlled radiofrequency energy to stimulate collagen production and improve skin texture and contour through non-invasive thermal effects.

This device is supplied as a reusable system with real-time temperature feedback for precise energy delivery. It operates in clinical settings and is intended for facial and body applications, including areas such as the forehead, nasolabial folds, and submental regions. Authorized under FDA 510(k) clearance and MDD compliance, the Oligio X incorporates safety features like skin impedance matching and temperature monitoring to ensure patient comfort and procedural safety.

Frequently asked questions

What types of skin areas can the Oligio X treat, and how does it achieve its effects?

The Oligio X is designed for non-invasive deep dermal remodeling on facial and body areas like the forehead, nasolabial folds, and submental regions. It delivers controlled monopolar radiofrequency (RF) energy to stimulate collagen production, improving skin texture and contour through thermal effects. The device’s real-time temperature feedback ensures precise energy delivery for patient comfort and safety.

Is the Oligio X intended for single-use or reusable applications, and what safety features does it include?

The Oligio X is supplied as a reusable system, meaning it can be used across multiple procedures. To ensure safety, it includes features like skin impedance matching and temperature monitoring, which help maintain patient comfort and procedural safety during RF energy delivery.

How is the Oligio X regulated, and what does its classification under product code GEI mean?

The Oligio X holds FDA 510(k) clearance and complies with the Medical Device Directive (MDD), confirming its regulatory approval. The product code GEI (General, Plastic Surgery) indicates it falls under the category of devices used for cosmetic or reconstructive procedures in plastic surgery, aligning with its intended use for deep dermal remodeling.

What clinical settings is the Oligio X intended for, and does it require any special handling?

The Oligio X is designed exclusively for clinical settings, such as dermatology or plastic surgery offices, where trained professionals can administer treatments. Since it is reusable, proper sterilization and maintenance protocols must be followed between uses to ensure hygiene and functionality.

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 ASIA | Oligio

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

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

Sources (2)

  • FDA 510(k) K240313 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026