# K231548: Medical Diode Laser, Model S1Pro

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Pioon Technology Co., Ltd.
- Decided: Aug 3, 2023 after 65 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: 4 generations back to K043046 (2005). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211977: Medical Diode Laser Systems, Wuhan Dimed Laser Technology Co., Ltd. (2021) Summary page 4.

## Indications for use
The Medical Diode Laser ,Model S1Pro is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Source page: https://510kreport.com/device/K231548
Methodology: https://510kreport.com/methodology