ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS— 510(k) K141280

Substantially Equivalent

Seinoh Optical Co. , Ltd.

FDA 510(k) clearance K141280 for ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS, Substantially Equivalent on 2014-07-18. Applicant: Seinoh Optical Co. , Ltd..

Clearance details

Applicant: Seinoh Optical Co. , Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2014-05-16
Decision date: 2014-07-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: New Taipei City, TW

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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.