510(k) K232649— Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

Substantially Equivalent

Pegavision Corporation

Clearance details

Applicant: Pegavision Corporation
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2023-08-31
Decision date: 2024-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan City, TW

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.