FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM— 510(k) K132475

Name: FDA 510(k) clearance K132475
Creator: U.S. Food and Drug Administration
Published: 2014-05-07

Substantially Equivalent

Fluoptics

FDA 510(k) clearance K132475 for FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM, Substantially Equivalent on 2014-05-07. Applicant: Fluoptics. Device class: 2.

Clearance details

Applicant: Fluoptics
Product code: Code OWN
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2013-08-07
Decision date: 2014-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orinda, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

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.