MODIFICATION TO PRISMALIX SURGICAL LIGHT— 510(k) K040015

Name: FDA 510(k) clearance K040015
Creator: U.S. Food and Drug Administration
Published: 2004-01-21

Substantially Equivalent

Alm S.A.

FDA 510(k) clearance K040015 for MODIFICATION TO PRISMALIX SURGICAL LIGHT, Substantially Equivalent on 2004-01-21. Applicant: Alm S.A.. Device class: 2.

Clearance details

Applicant: Alm S.A.
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2004-01-05
Decision date: 2004-01-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, 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

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K040735 — ALM X'TEN (X10) SURGICAL LIGHT SYSTEM2004-05-21

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 →

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