THE VISONIC DOME(TM)— 510(k) K902306

Substantially Equivalent

Vista Vision

FDA 510(k) clearance K902306 for THE VISONIC DOME(TM), Substantially Equivalent on 1990-12-21. Applicant: Vista Vision.

Clearance details

Applicant: Vista Vision
Product code: Code LYL
Advisory panel: Ophthalmic
Date received: 1990-05-22
Decision date: 1990-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LYL

product code LYL

Other: 1
Total: 1

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.