# K251919: Thulium Laser System (Deluxlase)

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Bestview Laser S&T Co., Ltd.
- Decided: Sep 26, 2025 after 95 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.
No later device cites it as a predicate yet.
0 of 136 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 5.

## Indications for use
Deluxlase 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/K251919
Methodology: https://510kreport.com/methodology