TRULIGHT 5520 AND TRULIGHT 5320— 510(k) K102758

Name: FDA 510(k) clearance K102758
Creator: U.S. Food and Drug Administration
Published: 2010-10-26

Substantially Equivalent

Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

FDA 510(k) clearance K102758 for TRULIGHT 5520 AND TRULIGHT 5320, Substantially Equivalent on 2010-10-26. Applicant: Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg. Device class: 2.

Clearance details

Applicant: Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2010-09-23
Decision date: 2010-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charleston, SC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSY

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K142984 — Leo Minor2014-10-29
K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT2014-09-30
K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT2014-08-07
K132551 — ZF 7202014-06-30
K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES2014-06-09

More clearances from Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

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K061317 — ILED2006-06-22

Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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 →

Recalls naming K102758

K-number listed on FDA's recall record

Z-0563-2016 — Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5Class II·Completed·Trumpf Medical Systems, Inc.·20151102

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102758.

Data sourced from openFDA. This site is unofficial and independent of the FDA.