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

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.

Clearance details

Applicant: Fluoptics
Product code: Code OWN
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 ↗

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.