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

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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1

Cited as predicate

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Device details

FDA 510(k) registration fields

K number
K253951
Device name
Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-12-10
Decision date
2026-03-06
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Surgical cuttingVascular treatmentOtherAcne treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
• Urethral Strictures
• Bladder Neck Incisions (BNI)
• Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors,
• Ablation of Benign Prostatic Hypertrophy (BPH),
• Transurethral incision of the prostate (TUIP)
• Holmium Laser Resection of the Prostate (HoLRP)
• Holmium Laser Enucleation of the Prostate (HoLEP)
• Holmium laser Ablation of the Prostate (HoLAP)
• Condylomas
• Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy
• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.
• Endoscopic fragmentation of kidney calculi
• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

Gastroenterology
Open and endoscopic Gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
• Appendectomy
• Polyps
• Biopsy
• Gall Bladder calculi
• Biliary/Bile duct calculi
• Ulcers
• Gastric ulcers
• Duodenal ulcers
• Non Bleeding Ulcers
• Pancreatitis
• Haemorrhoids
• Cholecystectomy
• Benign and Malignant Neoplasm
• Angiodysplasia
• Colorectal cancer
• Telangiectasias
• Telangiectasias of the Osler-Weber-Rendu disease
• Vascular Malformation
• Gastritis
• Esophagitis
• Esophageal ulcers
• Varices
• Colitis
• Mallory-Weiss tear
• Gastric Erosions

Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
• Ligament and tendon Release
• Contouring and sculpting of articular surfaces
• Capsulectomy in the Knee
• Chondreplasty in the Knee
• Debridement of inflamed synovial tissue
• Chondromalacia Ablation
• Chondromalacia and tears
• Plica Removal
• Meniscectomy
• Loose Body Debridement
• Lateral retinacular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including:
• Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty
• Percutaneous Cervical Disc Decompression/Discectomy
• Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue.

ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization

Intended Use

The Multicavity Holmium laser system and its fiber optic delivery system 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, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

Device Description

The HZ Series is a family of pulsed solid-state Holmium:YAG laser systems that deliver energy at a wavelength of 2100 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a diode-pumped Ho:YAG laser medium, and the laser energy is transmitted to the target site via SMA-905 compatible optical fibers. All models in the series share the same fundamental design and operational principles, differing in maximum average power output, Energy per pulse and frequency. The system includes a touchscreen interface, single-pedal footswitch, integrated liquid cooling, and multiple built-in safety features such as a key switch, emergency stop and door interlock, and real-time monitoring of laser output.

Summary parsed at:2026-06-01 05:19:01 UTC

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