EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear— 510(k) K161124

Substantially Equivalent

Vision Science Co., Ltd.

FDA 510(k) clearance K161124 for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Substantially Equivalent on 2016-08-26. Applicant: Vision Science Co., Ltd..

Clearance details

Applicant: Vision Science Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2016-04-21
Decision date: 2016-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeongsangbuk-Do, KR

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.