K243993

Substantially Equivalent

Photon Therapy Apparatus (BL-10)

Applicant: Xemis Medical Technology (Shenzhen) Co., Ltd.
Product code: GEX
Advisory panel: General, Plastic Surgery
Date received: 2024-12-26
Decision date: 2025-03-13
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.