AQUIFY LENS COMFORT DROPS— 510(k) K042176

Substantially Equivalent

Ciba Vision Corporation

FDA 510(k) clearance K042176 for AQUIFY LENS COMFORT DROPS, Substantially Equivalent on 2004-11-03. Applicant: Ciba Vision Corporation. Device class: 2.

Clearance details

Applicant
Ciba Vision Corporation
Product code
Code LPN
Device class
Class 2
Regulation
21 CFR 886.5928
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Duluth, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LPN

product code LPN
Injury
333
Other
8
Total
341

Source: openFDA MAUDE database, through . 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.