# K261817: Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)

- Pathway: 510(k) (Traditional)
- Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Decided: Sep 17, 2026 after 108 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: 26 generations back to K943450 (1995). 567 ancestors in all.
No later device cites it as a predicate yet.
0 of 568 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251329: Diode laser device (RF3120-BI), Risu Medical Technology Co., Ltd. (2025) Summary page 7.

## Indications for use
The Diode Laser Therapy System is intended for use in dermatological procedures requiring coagulation. The indications for use include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The HR Mode is intended for use in dermatological procedures requiring coagulation. The indications for use for the HR Mode include: Benign vascular and vascular dependent lesions.

Source page: https://510kreport.com/device/K261817
Methodology: https://510kreport.com/methodology