Holmium Laser Therapeutic Apparatus (3 models)— 510(k) K253951
Substantially EquivalentGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
FDA 510(k) clearance K253951 for Holmium Laser Therapeutic Apparatus (3 models), Substantially Equivalent on 2026-03-06. Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Device class: 2.
Summary
Guangzhou Potent Medical Equipment's Holmium Laser Therapeutic Apparatus comes in three listed models, HZ-A, HZ-B and HZ-E. They're filed under GEX, powered laser surgical instruments.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Guangzhou Potent Medical Equipment filed from Guangzhou, China. Review took 86 calendar days (December 10, 2025 to March 6, 2026).
Clearance details
- Device name as filed
- Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Product code
- Product 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.