# K230274: Medical Diode Laser (M2)

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Pioon Technology Co., Ltd.
- Decided: Mar 31, 2023 after 58 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: 23 generations back to K943450 (1995). 633 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 636 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193656: SkyPulse, Fotona D.O.O. (2020) Summary page 4.

## Most influential descendants
- K262426: Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) (2026), 0 descendants of its own
- K250656: Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (2025), 0 descendants of its own

## Indications for use
Medical Diode Laser is intended to incision,excision,ablation,vaporization, hemostasis and/or coagulation of soft tissue.

Source page: https://510kreport.com/device/K230274
Methodology: https://510kreport.com/methodology