Holmium Laser Therapeutic Apparatus (HZ-40)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253633
- Device name
- Holmium Laser Therapeutic Apparatus (HZ-40)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-11-19
- Decision date
- 2026-01-24
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingOtherVascular treatmentSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
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. The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones. The MultiPulse HoPLUS 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, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Intended 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.
Device Description
The HZ-40 Holmium Laser Therapeutic Apparatus 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 flashlamp-pumped Ho:YAG laser medium, and the laser energy is transmitted to the target site via SMA905-compatible optical fibers. The system includes a touchscreen interface, single-pedal footswitch, integrated liquid cooling, and multiple built-in safety features such as an emergency stop, door interlock, and real-time monitoring of laser output.
Summary parsed at:2026-06-01 05:18:48 UTC
Predicate devices
2—
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Not ingested
MultiPulse HoPLUS
K253633 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
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