# K261821: 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)

- Pathway: 510(k) (Traditional)
- Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Decided: Aug 27, 2026 after 87 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: 22 generations back to K910422 (1992). 325 ancestors in all.
No later device cites it as a predicate yet.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222790: F65 Laser System, Lumenis Be, Ltd. (2023) Summary page 7.

## Indications for use
The 1565nm Laser Therapy Device is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue, and improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type | to IV who are seeking treatment for hair loss.

Source page: https://510kreport.com/device/K261821
Methodology: https://510kreport.com/methodology