Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens— 510(k) K213216

Substantially Equivalent

Unicon Optical Co., Ltd.

FDA 510(k) clearance K213216 for Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens, Substantially Equivalent on 2022-01-18. Applicant: Unicon Optical Co., Ltd..

Clearance details

Applicant: Unicon Optical Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2021-09-29
Decision date: 2022-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baoshan Township, 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.