510(k) K252745— Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)

Substantially Equivalent

Micro-Energy Medical Technology Co., Ltd.

Clearance details

Applicant: Micro-Energy Medical Technology Co., Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2025-08-29
Decision date: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse 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, 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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.