Holmium Laser Therapeutic Apparatus (3 models)— 510(k) K253951

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

Code GEX

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2025-12-10

Decision date

2026-03-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Guangzhou, CN

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• K253633 — Holmium Laser Therapeutic Apparatus (HZ-40)2026-01-24
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Death

33

Injury

3,045

Malfunction

12,903

Other

25

Total

16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →