HALUX IRIS EXAMINATION AND SURGICAL LAMP— 510(k) K053364

Substantially Equivalent

Waldmann Lighting

FDA 510(k) clearance K053364 for HALUX IRIS EXAMINATION AND SURGICAL LAMP, Substantially Equivalent on 2006-02-23. Applicant: Waldmann Lighting.

Clearance details

Applicant: Waldmann Lighting
Product code: Code FTD
Advisory panel: General, Plastic Surgery
Date received: 2005-12-02
Decision date: 2006-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

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Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.