DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER— 510(k) K083288

Substantially Equivalent

Innova Vision, Inc.

FDA 510(k) clearance K083288 for DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER, Substantially Equivalent on 2009-09-03. Applicant: Innova Vision, Inc..

Clearance details

Applicant: Innova Vision, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2008-11-07
Decision date: 2009-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

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Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

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.