Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses— 510(k) K161739

Substantially Equivalent

Pegavision Corporation

FDA 510(k) clearance K161739 for Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Substantially Equivalent on 2016-12-19. Applicant: Pegavision Corporation.

Clearance details

Applicant: Pegavision Corporation
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2016-06-24
Decision date: 2016-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan City, 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.