AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES— 510(k) K120028

Substantially Equivalent

Pegavision Corporation

FDA 510(k) clearance K120028 for AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES, Substantially Equivalent on 2012-04-17. Applicant: Pegavision Corporation.

Clearance details

Applicant: Pegavision Corporation
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2012-01-04
Decision date: 2012-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan, TW

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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.