LIGHTWRITER— 510(k) K931855

Name: FDA 510(k) clearance K931855
Creator: U.S. Food and Drug Administration
Published: 1994-05-10

Substantially Equivalent

Zygo Corp.

FDA 510(k) clearance K931855 for LIGHTWRITER, Substantially Equivalent on 1994-05-10. Applicant: Zygo Corp.. Device class: 2.

Clearance details

Applicant: Zygo Corp.
Product code: Code ILQ
Device class: Class 2
Regulation: 21 CFR 890.3710
Advisory panel: Physical Medicine
Date received: 1993-04-13
Decision date: 1994-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ILQ

product code ILQ

Death: 4
Malfunction: 477
Total: 481

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.