VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens— 510(k) K242413

Substantially Equivalent

Vizionfocus, Inc.

FDA 510(k) clearance K242413 for VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens, Substantially Equivalent on 2024-12-17. Applicant: Vizionfocus, Inc..

Clearance details

Applicant: Vizionfocus, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2024-08-14
Decision date: 2024-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miaoli County, 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.