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

Name: FDA 510(k) clearance K053364
Creator: U.S. Food and Drug Administration
Published: 2006-02-23

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. Device class: 2.

Clearance details

Applicant: Waldmann Lighting
Product code: Code FTD
Device class: Class 2
Regulation: 21 CFR 878.4580
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTD

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K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT2013-12-05
K130513 — VOLISTA 400; VOLISTA 6002013-05-08
K123776 — POLARIS 100/2002013-03-08
K111020 — ATRICURE DISSECTOR2011-06-09
K100234 — HM-LAMP II2010-07-08

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.