NLITE SYSTEM, MODEL#: A00-1025/A00-1033— 510(k) K024189

Substantially Equivalent

Icn Photonics , Ltd.

FDA 510(k) clearance K024189 for NLITE SYSTEM, MODEL#: A00-1025/A00-1033, Substantially Equivalent on 2003-06-20. Applicant: Icn Photonics , Ltd..

Clearance details

Applicant: Icn Photonics , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2002-12-19
Decision date: 2003-06-20
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.