510(k) K191929— UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

Substantially Equivalent

Unicon Optical Co., Ltd.

Clearance details

Applicant: Unicon Optical Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2019-07-19
Decision date: 2019-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, 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.