Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
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
- K252771
- Device name
- Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-09-02
- Decision date
- 2025-11-24
- Submission type
- Traditional
- Technology type
- Er:YAG(AI inferred)
- Clinical applications
- Surgical cuttingOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Holmium laser 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, Gynecology, ENT and General Surgery.
Intended Use
The Holmium laser 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, Gynecology, ENT and General Surgery.
Device Description
Laser Source: Pulsed Ho:YAG (CHT:YAG). Wavelength: 2100 nm. Emission Mode: Pulsed. Pulse Duration: Up to 1700 µs. Pulse Energy: Up to 6.0 J. Frequency: Up to 120 Hz. Max Avg. Power: 90–150 W (model dependent). Delivery System: SMA905 optical fibers. Aiming Beam: Green diode < 3 mW. Cooling: Closed-loop liquid. Safety Systems: Key switch, door interlock, emergency stop, fiber detection, output monitoring.
Summary parsed at:2026-06-01 05:24:17 UTC
Predicate devices
2MultiPulse HoPLUS
Litho 150, Cyber Ho 150
K252771 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252771 as a predicate