# K241406: Lavieen

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Jun 28, 2024 after 42 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K910422 (1992). 135 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223727: Lavieen, Wontech Co., Ltd. (2023) Summary page 6.

## Most influential descendants
- K252732: 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) (2025), 1 descendant of its own
- K261589: 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) (2026), 0 descendants of its own

## 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).

Source page: https://510kreport.com/device/K241406
Methodology: https://510kreport.com/methodology