Lavieen

Wontech Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

2

Device details

FDA 510(k) registration fields

K number
K223727
Device name
Lavieen
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

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 05:32:22 UTC

Predicate devices

2

K223727 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K223727 as a predicate