AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES— 510(k) K140025

Substantially Equivalent

Pegavision Corporation

FDA 510(k) clearance K140025 for AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES, Substantially Equivalent on 2014-10-15. Applicant: Pegavision Corporation.

Clearance details

Applicant: Pegavision Corporation
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2014-01-06
Decision date: 2014-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan, TW

Download summary PDF View on FDA.gov ↗

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.