Skip to content

Lavieen

by Wontech Co., Ltd

510(k) K223727Ref Focused Ultrasound Stimulator System

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241406

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800022301107 Basic UDI-DI 08800022301107UDI-DIDate15 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241406 Date28 Jun 2024DecidedStatusActive
United StatesGUDID listing GUDID Number08800022301107 UDI-DI Date20 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK223727 Date25 Aug 2023ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800022301107 registered 15 May 2026 Active
  • FDA 510(k) K241406 decided 28 Jun 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800022301107 listed 20 Sep 2023 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K223727
  2. Listed FDA GUDID 08800022301107
  3. Cleared FDA 510(k) K241406
  4. Registered EUDAMED B-08800022301107

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
General/multiple surgical solid-state laser system
Model / reference
Focused Ultrasound Stimulator System EUDAMED
Lavieen GUDID
FDA applicant
Wontech Co., Ltd.
Primary DI / UDI-DI
08800022301107
Basic UDI-DI
B-08800022301107
510(k) Number
FDA product code
GEX
EMDN code
Z120615 Therapeutic lasers
GMDN term
General/multiple surgical solid-state laser system
Device class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / referenceEUDAMED
Focused Ultrasound Stimulator System
510(k)
—
GUDID
Lavieen
Device classEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lavieen is a surgical mesh designed for use in general and plastic surgery procedures. It is intended to provide reinforcement and support to soft tissues, aiding in the repair of hernias, pelvic organ prolapse, or other conditions requiring structural reinforcement.

Supplied as a sterile, single-use device, the Lavieen is intended for surgical settings and must be handled under aseptic conditions. It is classified under product code GEX and has received FDA 510K clearance under the Medical Device Directive (MDD). The device is available in various sizes and configurations as specified in the manufacturer’s documentation, with regulatory compliance ensuring its safety and performance for intended surgical applications.

Devices cleared under K223727

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K223727
UDI-DISize and differences
Lavieen
WONTECH CO., LTD
Lavieen08800022301107 —On the market
NOUVADerm
WONTECH CO., LTD
NOUVADerm08800022301121 —On the market

Similar devices in this category

Other devices filed under THERAPEUTIC LASERS.

Other devices from Wontech Co., Ltd

  • Oligio

    Class IIb

  • Tightan Pro

    Class IIa

  • NOUVADerm

    Class II

  • Air Gap Fiber AG365

    Class II

See all devices from Wontech Co., Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)