LGO-Surgical Laser Fibers— 510(k) K243147

Substantially Equivalent

Light Guide Optics International , Ltd.

FDA 510(k) clearance K243147 for LGO-Surgical Laser Fibers, Substantially Equivalent on 2024-12-21. Applicant: Light Guide Optics International , Ltd..

Clearance details

Applicant: Light Guide Optics International , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2024-09-30
Decision date: 2024-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Livani, LV

Download summary PDF View on FDA.gov ↗

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.