510(k) K242855— P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Substantially Equivalent

E.O.S Co., Ltd.

Clearance details

Applicant: E.O.S Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2024-09-20
Decision date: 2025-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

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.