NLITE SYSTEM,MODEL A00-1025— 510(k) K013461

Substantially Equivalent

Icn Photonics , Ltd.

FDA 510(k) clearance K013461 for NLITE SYSTEM,MODEL A00-1025, Substantially Equivalent on 2002-01-17. Applicant: Icn Photonics , Ltd..

Clearance details

Applicant: Icn Photonics , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2001-10-18
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Llanelli, GB

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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.