COLDLIGHTSOURCE PL3000— 510(k) K993300

Name: FDA 510(k) clearance K993300
Creator: U.S. Food and Drug Administration
Published: 1999-11-05

Substantially Equivalent

Fiber Imaging Technologies, Inc.

FDA 510(k) clearance K993300 for COLDLIGHTSOURCE PL3000, Substantially Equivalent on 1999-11-05. Applicant: Fiber Imaging Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Fiber Imaging Technologies, Inc.
Product code: Code FCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1999-10-01
Decision date: 1999-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.