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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

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Company

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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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)
Company
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
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

2

K252771 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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