THE VISONIC DOME(TM)— 510(k) K902306

Name: FDA 510(k) clearance K902306
Creator: U.S. Food and Drug Administration
Published: 1990-12-21

Substantially Equivalent

Vista Vision

FDA 510(k) clearance K902306 for THE VISONIC DOME(TM), Substantially Equivalent on 1990-12-21. Applicant: Vista Vision. Device class: 2.

Clearance details

Applicant: Vista Vision
Product code: Code LYL
Device class: Class 2
Regulation: 21 CFR 886.5928
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 ↗

Recent devices under product code LYL

view all

K211361 — 3N Contact Lenses Adjunct Cleaner2022-01-13
K210300 — VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System2021-04-01
K083757 — BPZ02 MULTIPURPOSE SOLUTION2009-11-18
K021699 — AUTOLENS CLEANING AND DISINFECTING UNIT2002-12-16
K022687 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION2002-11-19

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.