Lavieen
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Lavieen EUDAMEDFDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- Lavieen EUDAMEDTm-doped Fiber Laser System FDA UDI
- Model / Reference
- Focused Ultrasound Stimulator System EUDAMEDLavieen FDA UDI
- Description
- Tm-doped Fiber Laser System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800022301107 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800022301107 EUDAMED
- FDA Product Code
- GEX FDA 510(k)FDA UDI
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
- GMDN Term
- General/multiple surgical solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)FDA UDI
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
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.
Frequently asked questions
What types of surgical procedures is the Lavieen mesh intended to support, and how does it function in those cases?
The Lavieen mesh is designed for use in general and plastic surgery procedures where soft tissue reinforcement is needed. It provides structural support to aid in the repair of hernias, pelvic organ prolapse, or other conditions requiring durable reinforcement. The mesh acts as a scaffold to strengthen weakened tissues, helping to maintain anatomical integrity during healing.
Is the Lavieen mesh single-use only, and if so, why is this important for surgical settings?
Yes, the Lavieen mesh is supplied as a sterile, single-use device. This is critical in surgical settings because reusing a mesh could introduce contamination risks, compromise patient safety, and violate aseptic conditions. Single-use ensures each patient receives a new, uncontaminated device, reducing infection risks and maintaining regulatory compliance.
How is the Lavieen mesh regulated, and what does the FDA 510K clearance under the Medical Device Directive (MDD) imply about its safety and performance?
The Lavieen mesh received FDA 510K clearance under the Medical Device Directive (MDD) as a substantially equivalent device, meaning it has been evaluated and determined to have similar intended use, technological characteristics, and performance as a legally marketed predicate device. This clearance implies that the device meets regulatory standards for safety, effectiveness, and manufacturing quality, ensuring it is suitable for its intended surgical applications.
Are there multiple sizes or configurations available for the Lavieen mesh, and how might a clinician determine the appropriate size for a patient?
Yes, the Lavieen mesh is available in various sizes and configurations as outlined in the manufacturer’s documentation. The appropriate size depends on the specific surgical needs, such as the anatomical location and extent of tissue reinforcement required. Clinicians should refer to the manufacturer’s sizing guidelines or consult with surgical experts to select the most suitable mesh dimensions for each patient’s procedure.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223727 | Class II | Active |
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Manufacturer
- Manufacturer
- Wontech Co., Ltd
- FDA Applicant
- Wontech Co., Ltd.
Sources (3)
- FDA 510(k) K223727 24 fields · synced Sep 18, 2026
- FDA UDI b357c89a-44e7-4aca-9ab7-ead3aafdc20c 34 fields · synced May 30, 2026
- EUDAMED 4a5a8220-4b99-4a1e-a943-eb257427ddb6 61 fields · synced Jul 24, 2026