Lavieen
510(k) K241406
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241406 | Date28 Jun 2024 | StatusActive |
Official records
- FDA 510(k) database K241406
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Wontech Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
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.
Devices cleared under K241406
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.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Lavieen | Lavieen | 08800022301107 | — | On the market |
| NOUVADerm | NOUVADerm | 08800022301121 | — | On the market |
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