OLYMOUS XLS XENON LIGHT SOURCE— 510(k) K912354

Substantially Equivalent

Perkinelmer Optoelectronics

FDA 510(k) clearance K912354 for OLYMOUS XLS XENON LIGHT SOURCE, Substantially Equivalent on 1991-08-16. Applicant: Perkinelmer Optoelectronics.

Clearance details

Applicant: Perkinelmer Optoelectronics
Product code: Code GCT
Advisory panel: Gastroenterology, Urology
Date received: 1991-05-28
Decision date: 1991-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suunyvale, CA, US

Download summary PDF View on FDA.gov ↗

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.