Device details
FDA 510(k) registration fields
- K number
- K223727
- Device name
- Lavieen
- Company
- Wontech Co., Ltd.
- Country / region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-12-13
- Decision date
- 2023-08-25
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatmentSkin resurfacing
- Primary application
- Pigment treatment
- Classification source
- AI classified
