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Lavieen

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241406

by Wontech Co., Ltd

Identifiers

510(k) Number
K241406 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lavieen is a laser device. It is substantially equivalent and has a product code of GEX.

The Lavieen is supplied by Wontech Co., Ltd. and has received FDA 510K authorization with the k number K241406. It is used in general and plastic surgery, and has also been approved in Mexico and Saudi Arabia.

Frequently asked questions

What is the Lavieen device used for?

The Lavieen is used in general and plastic surgery, indicating its application in medical procedures requiring laser technology.

Is the Lavieen device authorized by regulatory bodies?

Yes, the Lavieen has received FDA 510K authorization with the k number K241406, and has also been approved in Mexico and Saudi Arabia.

What is the product code of the Lavieen device?

The Lavieen device has a product code of GEX, categorizing it within a specific group of medical devices.

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: wontech.com, "Proven in Brazil, Expanding in Mexico" — WONTECH Completes Its 'Two ..., Wontech's Lavieen Laser Device Gains Saudi Approval, Expanding Middle ...

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) K241406 24 fields · synced Sep 24, 2026