VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System— 510(k) K210300

Name: FDA 510(k) clearance K210300
Creator: U.S. Food and Drug Administration
Published: 2021-04-01

Substantially Equivalent

Vuesonic, LLC

FDA 510(k) clearance K210300 for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System, Substantially Equivalent on 2021-04-01. Applicant: Vuesonic, LLC. Device class: 2.

Clearance details

Applicant: Vuesonic, LLC
Product code: Code LYL
Device class: Class 2
Regulation: 21 CFR 886.5928
Advisory panel: Ophthalmic
Date received: 2021-02-03
Decision date: 2021-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYL

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K211361 — 3N Contact Lenses Adjunct Cleaner2022-01-13
K083757 — BPZ02 MULTIPURPOSE SOLUTION2009-11-18
K021699 — AUTOLENS CLEANING AND DISINFECTING UNIT2002-12-16
K022687 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION2002-11-19
K020802 — RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION2002-05-31

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.