# K250998: CO2 Laser Therapy System (Model: LFS-D9U)

- Pathway: 510(k) (Traditional)
- Applicant: Sanhe Lefis Electronics Co., Ltd.
- Decided: Dec 19, 2025 after 262 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: 9 generations back to K936109 (1994). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191518: CO2 Laser System, Shenzhen Gsd Tech Co., Ltd. (2019) Summary page 6.

## Indications for use
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The Classical scanner is only for the treatment of wrinkles and skin resurfacing.

Source page: https://510kreport.com/device/K250998
Methodology: https://510kreport.com/methodology