# K253633: Holmium Laser Therapeutic Apparatus (HZ-40)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Decided: Jan 24, 2026 after 66 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: 8 generations back to K936109 (1994). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141403: Litho DK30, Quanta System Spa (2014) Summary page 5.
- K161257: MultiPulse HoPLUS, Asclepion Laser Technologies GmbH (2017) Summary page 5.

## Indications for use
Holmium Laser Therapeutic Apparatus are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and stone fragmentation in use in medical specialties including: Urology, Gastroenterology, ENT, Gynecology and general surgery.

Source page: https://510kreport.com/device/K253633
Methodology: https://510kreport.com/methodology