MI-15 EXAM SURGICAL LIGHT— 510(k) K930897

Name: FDA 510(k) clearance K930897
Creator: U.S. Food and Drug Administration
Published: 1993-06-25

Substantially Equivalent

Medical Illumination, Inc.

FDA 510(k) clearance K930897 for MI-15 EXAM SURGICAL LIGHT, Substantially Equivalent on 1993-06-25. Applicant: Medical Illumination, Inc.. Device class: 2.

Clearance details

Applicant: Medical Illumination, Inc.
Product code: Code FTD
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1993-02-22
Decision date: 1993-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arleta, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medical Illumination, Inc.

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K931026 — MI-5 DIAGNOSTIC LIGHT1993-08-19
K931646 — MI-4 VARIABLE SPOT LIGHT1993-08-19
K925710 — M.E.D. LIGHT1993-06-04
K922278 — ILLUMINATOR III1993-03-04
K922282 — ILLUMINATOR VIII ULTRA/SPOT1993-03-04

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.