UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR— 510(k) K141917

Substantially Equivalent

Unicon Optical Co., Ltd.

FDA 510(k) clearance K141917 for UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR, Substantially Equivalent on 2014-10-17. Applicant: Unicon Optical Co., Ltd..

Clearance details

Applicant: Unicon Optical Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2014-07-15
Decision date: 2014-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei, 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.