510(k) K220045— TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Substantially Equivalent

Dk Medivision Co., Ltd.

Clearance details

Applicant: Dk Medivision Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2022-01-05
Decision date: 2022-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chungcheongnam-Do, 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.