# K223727: Lavieen

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Aug 25, 2023 after 255 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: 15 generations back to K910422 (1992). 134 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171009: LASEMD Laser System, Lutronic Corporation (2017) Summary page 5.
- K182173: Joule System, Sciton, Inc (2019) Summary page 5.

## Most influential descendants
- K241406: Lavieen (2024), 2 descendants of its own
- 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
- K251919: Thulium Laser System (Deluxlase) (2025), 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/K223727
Methodology: https://510kreport.com/methodology