SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT— 510(k) K974724

Name: FDA 510(k) clearance K974724
Creator: U.S. Food and Drug Administration
Published: 1998-03-02

Substantially Equivalent

Lens Comfort, Inc.

FDA 510(k) clearance K974724 for SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT, Substantially Equivalent on 1998-03-02. Applicant: Lens Comfort, Inc.. Device class: 2.

Clearance details

Applicant: Lens Comfort, Inc.
Product code: Code LYL
Device class: Class 2
Regulation: 21 CFR 886.5928
Advisory panel: Ophthalmic
Date received: 1997-12-18
Decision date: 1998-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elizabeth, NJ, US

Download summary PDF View on FDA.gov ↗

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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.