# K250782: Fractional CO2 Laser Machine

- Pathway: 510(k) (Traditional)
- Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Decided: Jun 12, 2025 after 90 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: 20 generations back to K943450 (1995). 282 ancestors in all.
No later device cites it as a predicate yet.
0 of 283 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172096: Fraxis, Ilooda Co,., Ltd. (2017) Summary page 6.

## Indications for use
Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode (Impulse mode) is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

Source page: https://510kreport.com/device/K250782
Methodology: https://510kreport.com/methodology