Holmium Laser System (5 models)— 510(k) K252771
Substantially EquivalentGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
FDA 510(k) clearance K252771 for Holmium Laser System (5 models), Substantially Equivalent on 2025-11-24. Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- 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)
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code GEX
view allMore clearances from Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.