# K253951: Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Decided: Mar 6, 2026 after 86 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: 13 generations back to K936109 (1994). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201455: Litho 150, Cyber Ho 150, Quanta System Spa (2020) Summary page 6.

## 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 in use in medical specialties including: Urology,Urinary Lithotripsy, Gastroenterology,ENT, Gynecology and general surgery.

Source page: https://510kreport.com/device/K253951
Methodology: https://510kreport.com/methodology