EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear— 510(k) K153305

Substantially Equivalent

Eyeyon Medical

FDA 510(k) clearance K153305 for EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear, Substantially Equivalent on 2016-04-08. Applicant: Eyeyon Medical.

Clearance details

Applicant: Eyeyon Medical
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2015-11-16
Decision date: 2016-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nes Ziona, IL

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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.