Manufacturer
Wontech Co., Ltd.Lavieen
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K241406
- 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
- 2024-05-17
- Decision date
- 2024-06-28
- Submission type
- Traditional
- Technology type
- Thulium fiber(AI inferred)
- Clinical applications
- Skin resurfacingPigment treatmentVascular treatmentOther
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Intended Use
Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Device Description
Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. Lavieen is equipped with a 658 nm aiming beam.
Summary parsed at:2026-06-01 05:28:18 UTC
Predicate devices
1Lavieen
K241406 references 1 predicate/reference device
Cited as predicate
11927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
1 submission cite K241406 as a predicate