K250113

Substantially Equivalent

neoLaser Laser Surgery Fibers

Applicant: G.N.S Neolaser , Ltd.
Product code: GEX
Advisory panel: General, Plastic Surgery
Date received: 2025-01-16
Decision date: 2025-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

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.