WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175— 510(k) K963227

Name: FDA 510(k) clearance K963227
Creator: U.S. Food and Drug Administration
Published: 1996-10-23

Substantially Equivalent

Products For Medicine

FDA 510(k) clearance K963227 for WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175, Substantially Equivalent on 1996-10-23. Applicant: Products For Medicine. Device class: 2.

Clearance details

Applicant: Products For Medicine
Product code: Code GCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1996-08-19
Decision date: 1996-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Quinta, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCT

product code GCT

Malfunction: 1,393
Other: 2
Total: 1,395

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.